Invasive access devices and affiliated disposables (including urinary catheters, drains and blood bags)

Publications
We have issued several dedicated documents relating to catheters, needle free connectors, IV and epidural devices and blood collection devices. These include:

• product specific medical device alerts.
• generic information in the form of alerts/leaflets/posters,

Alerts (medical device alerts, safety notices, hazard notices and device alerts) issued prior to 2007 are available from our Safety warnings section on our website. Those issued since 2007 are listed below.

Medical device alerts issued since the beginning of 2007
Fluid warming set: Level 1 normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical.
Small holes have been found in the inner lumen (aluminium tube) of some sets which can allow leakage of the heating fluid into the infusate with the potential for contamination.
› MDA/2007/064 - Fluid warming set: Level 1 normothermic IV fluid administration and irrigation sets - D/DI and IR/IRI series manufactured by Smiths Medical

Enteral feeding pumps: ClearStar model number M771 manufactured by Abbott Nutrition.
Risk of under-infusion due to cracking/breaking of internal adapter bracket. The manufacturer has initiated an accelerated service programme of specific serial numbers of these pumps.
› MDA/2007/060 - Enteral feeding pumps: ClearStar model number M771 manufactured by Abbott Nutrition

IV extension lines: model 6222 range of V Green narrow bore extension lines manufactured by Vygon (UK) Ltd.
There is a potential for the female connector of the line to crack when used to deliver propofol (an intravenous anaesthetic agent).  This may result in leakage of this drug and failure to induce and maintain general anaesthesia. The manufacturer has initiated a recall of specific batch numbers irrespective of the drugs they are being used with.
› MDA/2007/053 - IV extension lines: model 6222 range of V-Green narrow bore extension lines manufactured by Vygon (UK) Ltd

All brands of needle-free intravascular connectors.
The instructions for several brands of these devices have changed significantly in the last two years.
› MDA/2007/051 - All brands of needle-free intravascular connectors

Single-use capillary blood sampling device: Microtainer® Safety Flow Lancets manufactured by BD Preanalytical Systems. Product codes 366354, 366355 and 366358.
Potential for a sharps injury to patient or user as the blade may become loose and then separate from the main body on activation of the device. The manufacturer has recalled the affected lot numbers of these products.
› MDA/2007/049 - Single-use capillary blood sampling device: Microtainer® Safety Flow Lancets manufactured by BD Preanalytical Systems

Devices for securing lines, tubes and drains: Drain-Fix 680M and 685M; Central-Gard 667M and 668M; Epi Fix 670M. All manufactured by Unomedical Ltd.
A packaging problem that may affect one in six of the manufactured peel pouches may compromise the sterility of the devices.  Therefore the manufacturer is recalling all affected batches.
› MDA/2007/048 - Devices for securing lines, tubes and drains: Drain-Fix 680M and 685M; Central-Gard 667M and 668M; Epi Fix 670M - All manufactured by Unomedical Ltd

IV solution administration set: models 3101-PNOY, 3101-PVJ and 3101-PN3 manufactured by Arcomedical Infusion Ltd.
Two manufacturing faults have resulted in either: the delivery accuracy rate being outside the specification when using models 3101-PNOY and 3101-PVJ with volumetric pumps, or free-flow when using model 3101-PN3 with volumetric pumps. Therefore the manufacturer is recalling specific lots.
› MDA/2007/047 - IV solution administration set: models 3101-PNOY, 3101-PVJ and 3101-PN3 manufactured by Arcomedical Infusion Ltd

Medication cassette reservoir for CADD legacy infusion pumps manufactured by Smiths Medical: model numbers 21-7001-24 and 21-7002-24.
In certain batches of medication cassette reservoirs there was a change of material formulation, to include calcium carbonate. There have been reports of shifts in pH of medication, discolouration and occlusions, which may or may not be related to this change. Until further evidence is obtained, it is recommended that these batches are not used.
› MDA/2007/044 - Medication cassette reservoir for CADD legacy infusion pumps manufactured by Smiths Medical: model numbers 21-7001-24 and 21-7002-24

Single-use capillary blood sampling device: Unistik 3 Normal, Unistik 3 Comfort and Unistik 3 Neonatal & Laboratory devices. Manufactured by Owen Mumford. Product codes AT1002, AT1042 and AT1052.
Potential for needlestick injury to users and damage to a patient’s sampling site due to a manufacturing fault. The manufacturer recalled five batches of these products that were distributed during the period 06 September to 07 November 2006.
› MDA/2007/022 - Single-use capillary blood sampling device: Unistik 3 Normal, Unistik 3 Comfort and Unistik 3 Neonatal & Laboratory devices. Manufactured by Owen Mumford. Product codes AT1002, AT1042 and AT1052

Fluid warming administration set: Smiths Medical Level 1® normothermic IV fluid administration set. Catalogue number DI-60HL (NHS Supply Chain code FFF265)
A manufacturing fault in the administration set can prevent appropriate warming of the blood/fluid to be administered, leading to a delay in patient treatment. The manufacturer is recalling specific lots.
› MDA/2007/015 - Fluid warming administration set: Smiths Medical Level 1® normothermic IV fluid administration set

Baxter Continu-Flo solution sets with check valve. Affected product codes: EMC 9603, RMC 9603, RMC 9604, RMC 9619.
During secondary infusions, there is the potential for solution from the secondary infusion container to pass through the check valve (one-way valve) on the primary line/set and consequently enter the primary infusion container (‘backflow‘). This backflow will be characterised by a rise of the fluid level in the drip chamber below the primary infusion container. Backflow can result in inadequate treatment by causing an under-infusion of the secondary infusion.
› MDA/2007/010 - Baxter Continu-Flo solution sets with check valve

Chest drain: Portex chest drainage system with adjustable straw. Product code 200/870/000, lot number 489962. Manufactured by Smiths Medical.
Failure to create a seal when the system is connected to the chest drainage bottle leaving the patient at risk of a pneumothorax. The manufacturer is recalling one lot of this device.
› MDA/2007/006 - Chest drain: Portex chest drainage system with adjustable straw

Vygon (UK) Ltd paediatric IV bacterial filter with extension line. Product code: 0807.205 (NHS Supply Chain code: FTC215). Batch numbers: 050805AA, 020905AA, 160905AA, 180205AA, 030605AA and 180705AA.
Cracking of the green hub on the filter has resulted in leakage. The manufacturer is recalling specific batches.
› MDA/2007/004 - Vygon (UK) Ltd paediatric IV bacterial filter with extension line

Generic publications (from the last five years)
Implanted venous access devices
We received several reports of problems associated with implanted venous access devices. These were trended into themes and tips were provided in a leaflet.

Intravascular and epidural devices
Many reports relating to intravascular and epidural devices relate to usage and practice problems rather than device failures. Many of the common problems were highlighted in a top tips leaflet.

Lancing devices
Transmission of hepatitis B between nursing home residents has been linked with the use of the wrong sort of lancing device. This has resulted in acute infections and deaths. Therefore MHRA published MDA/2006/066 on Lancing devices used in nursing homes and care homes. This was reinforced by a press release.

DEHP
We receive many enquires related to phthalates, in particular DEHP, and there use in plastic disposables. We have a question and answer webpage on this topic.

Contrast media
We have issued MDA/2004/010 on contrast media and central venous catheters. We also have a webpage relating to the use of contrast media injectors.

Cardiac Tamponade
In 2001, the publication  “Review of the deaths of four babies due to cardiac tamponade associated with the presence of a central venous catheter” (external link) was published and made several recommendations which DH responded to (external link). As a result DA 2001(04) - The use of central intravenous access in neonatal parenteral feeding  was published.
Further incidents were received relating to tamponade and hence MHRA published MDA/2003/020 entitled “Central venous catheters, including dialysis catheters, dilators and guidewires - Inappropriate choice and over-insertion of device leading to fatal consequences”.

Other generic notices (from the last five years)
All brands of needle free intra-vascular connectors.
The instructions for use of many brands of needle free connectors have undergone significant changes, in particular to the maximum period of use of the device.
› MDA/2005/030 - All brands of needle free intra-vascular connectors

Central venous catheter and pacing lead introducer kits.
Misuse of guidewire straighteners; potential for venous embolisation.
› MDA/2005/053 - Central venous catheter and pacing lead introducer kits

Needle free intravenous connectors
Incompatibility of some pre-filled glass syringes with various needle free connectors. Possible risk of infection and/or air embolus to patients when an adaptor remains attached to a needle free connector after use.
› MDA/2004/005 - Needle free intravenous connectors

Central Venous Catheters (all manufacturers)
Risk of catheter rupture during contrast CT investigation due to over- pressurisation when used with a powered injector.
› MDA/2004/010 - Central Venous Catheters (all manufacturers)

Contacts for further information
Nicole Toyick: nicole.toyick@mhra.gsi.gov.uk or 020 7084 3310
Ainsley Wickens: ainsley.wickens@mhra.gsi.gov.uk or 020 7084 3273
Louise Mulroy : louise.mulroy@mhra.gsi.gov.uk or  020 7084 3344
Enitan Taiwo: enitan.taiwo@mhra.gov.gsi.uk or 020 7084 3122

Device problems can be reported to MHRA online.