BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMINGTON MEDICAL DISPOSABLE PACING CABLE

    MDR report key: 417162 · Received September 13, 2002

    Report

    Report Number
    MW1026187
    Event Type
    Malfunction
    Date Received
    September 13, 2002
    Date of Event
    September 3, 2002
    Report Date
    September 3, 2002
    Manufacturer
    REMINGTON MEDICAL
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO SETS OF CABLES CAME OUT OF STERILE WRAP WITH EXPOSED WIRES NEAR PT CONNECTION. NOT USED ON PT.

    Description of Event or Problem · 1

    MODEL NUMBER S-101-97 (K922009B) (K971968). MFG LOT# 021893 NOT 021894. AS STATED BY THE CUSTOMER AND ENTERED INTO THE CO'S PRODUCT COMPLAINT FORM: "OPENED TYVEK POUCH TO USE S-101-97 IN A CASE. CABLE WAS REMOVED FROM POUCH AND UNROLLED. IMMEDIATELY NOTICED EXPOSED WIRE TOWARDS ALLIGATOR CLIP END OF CABLE. DISCARDED CABLE PRIOR TO USE. TRIED ANOTHER CABLE WITH SAME OUTCOME, DISCARDED CABLE PRIOR TO USE. THIRD CABLE IN PERFECT CONDITION PROCEEDED WITH CASE. CASE SUCCESSFUL, NO ADD'L INCIDENTS." THE DEVICE WAS RETURNED TO FACILITY ON 09/04/02. IT WAS HELD IN REMINGTON MEDICALS' HOLD AREA UNTIL CO COMPLETED THEIR INVESTIGATION AND MET WITH THE WIRE VENDOR (VIA TELEPHONE CONFERENCE). WAS SENT TO WIRE VENDOR ON 09/27/02 FOR THEIR EVAL. THE S-101-97 CABLE IS A SINGLE USE DISPOSABLE DEVICE. THIS COMPLAINT IS THE FIRST COMPLAINT THAT REMINGTON MEDICAL HAS EVER REC'D REGARDING EXPOSED WIRE. ADD'L INFO REC'D FROM MFR 11/21/02: COMPLAINT DESCRIPTION: AS SOON AS THE CUSTOMER REMOVED THE S-101-97 CABLE FROM THE TYVEK POUCH THEY NOTICED EXPOSED WIRE TOWARDS THE ALLIGATOR CLIP END OF THE CABLE. THIS HAPPENED TWICE AT THE SAME PROCEDURE. IN BOTH CASES THE PROBLEM WAS NOTED, THE CABLE DISCARDED AND WAS NOT USED ON THE PT. SUMMARY OF EVENTS: AS SOON AS MFR RECEIVED THE PRODUCT COMPLAINT THEY VERIFIED THE COMPLAINT. THE COPPER WAS EXPOSED. MFR SPOKE WITH THE MFR'S REP FOR THE WIRE MFR AND REVIEWED THE PROBLEM WITH HIM. MFR WAS INSTRUCTED TO RETURN THE PROBLEM PRODUCT TO THE WIRE MFR. THEY DID THIS ALL WITHIN 4 DAYS OF THE COMPLAINT. IMMEDIATELY STOPPED THE USE OF THIS WIRE ON ALL FUTURE WORK ORDERS. HAVE A SECOND SOURCE APPROVED AND BEGAN TO USE THE WIRE FROM THAT VENDOR AND QUARANTINED THE WIRE FROM THE VENDOR PRODUCING THE PROBLEM WIRE. AS PART OF FAILURE INVESTIGATION INSPECTED APPROX 100 UNITS OF FINISHED GOODS INVENTORY OF VARIOUS PRODUCT MADE WITH THIS WIRE. ABLE TO SEE THE EXPOSED WIRE ISSUE ON LESS THAN 5% OF THE PRODUCT INSPECTED. THE DEFECT WAS EITHER IMMEDIATELY NOTICEABLE UPON OPENING THE TYVEK POUCH OR UPON PULLING SLIGHTLY ON THE CABLE (WHICH IS DONE DURING THE ACTUAL USE OF THE CABLE). IF THE PHYSICIAN WERE TO USE A CABLE WITH SOME EXPOSED WIRE, THE WORST-CASE SCENARIO IS THAT THE EXPOSED COPPER WOULD COME IN CONTACT WITH SOME METAL OBJECT. THIS IS A SURGICAL PROCEDURE, THE PT WOULD BE DRAPED AND WHERE THE CABLE IS POSITIONED IT IS HIGHLY UNLIKELY THAT THERE WOULD BE ANY METAL IN THAT AREA FOR THE WIRE TO CONTACT. HOWEVER, IF IT WERE TO HAPPEN, THE PHYSICIAN WOULD BE ALERTED BY A FALSE READING AND READJUST OR CHANGE THE CABLE. THE PROTOCOLS FOR THESE PROCEDURES CALL FOR MULTIPLE PACKS OF THE APPROPRIATE CABLE BE AVAILABLE. THE MAJORITY OF THE PRODUCT MADE WITH THIS WIRE IS SINGLE USE DISPOSABLE PRODUCT. BASED ON THE LOW NUMBERS SEEN IN THE CO'S FINISHED GOODS INVENTORY AND THE REVIEW OF THE WORST-CASE SCENARIO, COUPLED WITH THE FACT THAT CO HAD ONLY ONE FIELD COMPLAINT, CO ELECTED TO CONTINUE TO SHIP THE PRODUCT. ON OCTOBER 10, 2002 MFR ISSUED A FORMAL WRITTEN COMPLAINT TO THE VENDOR INVOLVED AND ATTACHED A CORRECTIVE ACTION REQUEST FORM. THEY GAVE THE VENDOR A DEADLINE OF 10/31/02. ON 10/23/02 MFR RECEIVED A SECOND COMPLAINT. EXACTLY LIKE THE FIRST. THE CUSTOMER DISCARDED THE CABLE WHEN THEY SAW THE WIRE AND DID NOT USE ON THE PT. AS OF 11/20/02, MFR HAS NOT HEARD FROM THE VENDOR, NOR HAVE THEY HAD ANY ADD'L COMPLAINTS. REMINGTON MEDICALS' FINISHED GOODS INVENTORY OF THESE CABLES TURN APPROX EVERY 30 DAYS. INVENTORY AT CUSTOMERS' FACILITIES TURN, ON AVERAGE, BETWEEN 30 AND 45 DAYS. MFR IS STILL PRESSURING THE VENDOR TO RETURN ITS CORRECTIVE ACTION REQUEST AND WILL CONTINUE TO DO SO. MFR WILL, HOWEVER, NOT PURCHASE ANY MORE WIRE FROM THIS COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMINGTON MEDICAL DISPOSABLE PACING CABLE PATIENT CABLE DSA REMINGTON MEDICAL S-101-97 021894M

    Patients

    Seq Age Sex Outcome Treatment
    1 *