BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRI IMPLANTED PORT

    MDR report key: 529997 · Received May 27, 2004

    Report

    Report Number
    MW1032236
    Event Type
    Other
    Date Received
    May 27, 2004
    Report Date
    May 27, 2004
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/5/04: THE REPORTED EVENT DID OCCUR - TRANSPOSING OF THE MONTH AND YEAR ON THE EXPIRATION DATE. THE INVESTIGATION OF THIS MATTER AFTER RECEIVING A COMPLAINT TOOK A FEW DAYS. ONCE THIS INFO WAS AVAILABLE FROM THE MANUFACTURING LOCATION, THE CAUSE AND CORRECTIVE ACTIONS WERE DISCUSSED AND APPROVED BY BOTH THE DIVISION AND THE CORPORATE OFFICES, WHICH TOOK ADDITIONAL TIME. THE CORRECTIVE ACTION WAS TO OVERLABEL THE KITS AT THE FACILITIES THEY WERE SHIPPED TO. THE LABELS WERE SENT TO THE SALES PERSONNEL IN THE FIELD FOR THEIR NECESSARY ACTION. IFU REQUIRES THE KIT AND THE EXPIRATION TO BE CHECKED PRIOR TO USE, WHICH CO DEPENDED ON TO COVER THEM UNTIL THE INVESTIGATION WAS COMPLETE AT MFR'S END.

    Description of Event or Problem · 1

    ONE HOSPITAL PHYSICIAN IMPLANTED A CATHETER. ONCE THE DEVICE WAS IMPLANTED IT WAS NOTED THAT THE PACKAGING STATED AN EXPIRATION DATE OF 09/01. UPON NOTING THAT THE PACKAGING IMPLIED THE DEVICE WAS ALREADY EXPIRED THE PHYSICIAN EXPLANTED THE DEVICE AND IMPLANTED ANOTHER TO REPLACE IT. HOSPITAL WAS INFORMED THAT THE PACKAGING INFO WAS TRANSPOSED AND THE REAL EXPIRATION WAS JANUARY OF 09. REPORTER'S COMPLAINT IS THAT IF THE COMPANY WAS AWARE OF THIS MISTAKE THEY SHOULD HAVE MADE EFFORTS TO MAKE HOSPITAL AWARE OF THE PROBLEM IMMEDIATELY. REPORTER WAS INFORMED THAT THE SALES PEOPLE WERE GIVEN REPLACEMENT STICKERS THE PREVIOUS WEEK THAT WERE SUPPOSED TO BE PLACED OVER THE MISTAKEN DATES. REPORTER FEELS STEPS NEED TO BE TAKEN TO ENSURE THIS TYPE OF THING DOESN'T HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI IMPLANTED PORT OPEN ENDED SINGLE LUMEN VENOUS CATHETER LJT BARD ACCESS SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other