BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNG LUM Y LS/LJ 20CM CAT

    MDR report key: 368385 · Received December 21, 2001

    Report

    Report Number
    1720496-2001-00522
    Event Type
    Malfunction
    Date Received
    December 21, 2001
    Date of Event
    November 13, 2001
    Report Date
    November 30, 2001
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RETURNED THE PRODUCT TO THE DEALER BECAUSE THE CUSTOMER FOUND A UNIT FROM SAME LOT WITH LEAK OF BLOOD JUST OVER THE CLAMP. THE CUSTOMER BELIEVES THAT IT MUST BE A MICROPORE. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58284 SNG LUM Y LS/LJ 20CM CAT IMPLANTED BLOOD ACCESS DEVICE MSD BARD REYNOSA S.A. DE C.V. 5541700 22AL4971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other