Hazard Notices and
Safety Action Bulletins.

April 2000

MDA HN2000 MEDITECK LTD PRODUCTS : WITHDRAWAL FROM USE

This notice states that action is being taken against Mediteck Ltd regarding a number of dressing products and latex gloves, as the safety and sterility of these devices cannot be assured.

The notice gives details of products that should be withdrawn from use immediately.

Sep 1999

NAW SAB(99)31/MDA SN1999(31) Foam mattresses: prevention of cross infection.

This notice highlights the problems associated with poor maintenance of foam mattresses and their covers. Damage to the covers or permeation of fluid through the cover has lead to contamination of the mattresses with blood of body fluids, which is a potential infection hazard to staff and patients.

The MDA provide advice on inspection of mattresses and covers, and recommend implementing a local policy to deal with care, maintenance and cleaning.

Aug 1999

MDA HN1999(05) concerns Shiley Tracheostomy Tubes

Mallinckrodt have identified a number of Shiley adult dual cannula tracheostomy tubes where 0.005% may experience lug pin breakage, resulting in separation of the tube from the neck flange. They were manufactured between January and November 1998.

Mallinckrodt have initiated a manufacturers recall on affected lots as follows:

Catalog Nos DCT, DFEN, DCFS, DCFN, PERC, Lots from M80233000 to M86559000, also including lots M88059000 and M88080000

Catalog Nos LPC, FEN, CFN, CFS, LGT, Lots from M85013000 to M86544000, also including lots M88053000, M88054000, M88055000, M88058000, M88073000, M88074000, M88049000 and M88293000.

Enquiries to the manufacturer should be addressed to Ms Deidre Hayes, Mallinckrodt, Athlone, Ireland. Tel: 00353-902-75210, Fax: 00353-902-75219.

May 1999

MDA SN1999(21) concerns Baxter Healthcare DCR Flogard Infusion Pumps.

The MDA has received reports of over infusion due to the administration sets being forcibly removed from the pumps without the blue or orange safety clamp buttons being pressed.

The over-infusions were due to the set being reloaded over the safety clamps and the door being forced shut.

June 1998

WO SAB (98)24/MDA SN 9824, concerns a Flexiflo II Enteral Feeding Pump Transformer from Abbott Laboratories.

Advice is given on how to identify the affected transformers, and what action to take subsequently.

March 1998

WO SAB (98)10/MDA SN 9810 notes the withdrawal of Department of health specifications and product approval schemes for chemical indicators used in the Bowie and Dick test. The notice states that users must now take steps to introduce indicator sheets which conform with CEN standard BS EN 867:1997. An alternative for daily B-D testing is to use a total test pack conforming with BS 7720:1995.

They conclude that indicator tape should now no longer be used for the B-D test.

February 1998

WO SAB (98)08/MDA SN 9808 concerns a recall of Hewlett Packard defibrillation electrode pads (LOT numbers 020997, 030997, 040897, 050897, 200897, and 260897, for use with HP Codemaster and Codemaster 100 defibrillators) due to deterioration of the gel.

WO SAB (98)09/MDA SN 9809 concerns Laerdal Medical Heartstart defibrillation electrodes, Cat no 902402, LOT codes May 1999 and July 1999. Detachment of the female connector may occur when disconnecting the patient cable from the electrode. Advice is given how to avoid this.

August 1997

WO SAB (97)21 / MDA SN 9711, notes that users of IVAC 597 and 598 infusion pumps which are not maintained regularly may be subject to over-infusion. Alaris medical systems recommend checking of all 597 and 598 pumps in accordance with the calibration procedure available from them.

Alaris telephone no: (+44) 1256 474 455
Alaris Fax no: (+44) 1256 333 225

June 1997

MDA HN 9709 June 1979, issued in June 1997, advises users that a proportion of epidural connectors supplied with SIMS Portex epidural catheters, mini-packs and regional anaesthesia trays, contain a defective component, which prevents the connector from being fully tightened. Sims Portex are withdrawing all affected product from the market. The bulletin lists the affected product codes and batches. Further information from Mr J. Hulme, SIMS Portex , UK Tel: +44 (0) 1303-208040, Fax +44 (0) 1303-240743.

May 1997

MDA HN 9708, issued in May 1997, advises of a problem with shelf pessaries (Simpson Pessaries) made by GTS and supplied by Southern Syringe. The coating of these pessaries is liable to disintegrate or peel, and this is compounded by inadequate packaging, so that there is no way of identifying the product or manufacturer. In addition, no sterilisation or usage instructions are supplied.

The notice advises that the pessaries should not be used, and devices in use should be replaced with an alternative product as soon as possible.

Enquiries on technical aspects to Dr Alison Austin at the MDA (+44 (0) 171-972-8223), on clinical aspects to Dr S. Ludgate at the MDA (+44 (0) 171-972-8123), or to Mr Ian Paul, Southern Syringe Services, UK (+44 (0) 181-882-1971).

April 1997

MDA HN 9703, issued in April 1997, advises users of Baxter sterile blood administration sets, Code FMC 2090A (batch numbers between 96H28V278 and 97B24V339), Code FMC 2090 (batch numbers between 96H30V275 and 97C25V338), and Code FMC 2071A (batch numbers between 96I03V461 and 97C03V522), to be aware of potential failures of the roller clamp.

March 1997

MDA HN 9702, issued in March 1997, advises users not to reconnect partly used bags of intravenous fluids to administration sets, because of the risk of air embolism.

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Last Modified: Thursday, 04-May-2000 14:53:44 BST