BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCGAW FILTER V5412

    MDR report key: 284521 · Received June 29, 2000

    Report

    Report Number
    MW1019218
    Event Type
    Other
    Date Received
    June 29, 2000
    Date of Event
    June 26, 2000
    Report Date
    June 28, 2000
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S FAMILY MEMBER CALLED RPTR TO SAY LINE DELIVERING CHEMO (5FU) WAS LEAKING. THEY WERE INSTRUCTED TO TURN OFF PUMP. RN VISITED ASAP. DETERMINED LEAK TO BE AT PLASTIC SEAM OF ADD ON FILTER WHERE BLUE AND CLEAR PLASTIC PIECES CONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGAW FILTER V5412 0.22 MICRON FILTER 15 "MALE LL" FPB B. BRAUN MEDICAL, INC. * 060102499

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other