BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILE BAG REGULAR

    MDR report key: 64594 · Received January 24, 1997

    Report

    Report Number
    MW1010608
    Event Type
    Other
    Date Received
    January 24, 1997
    Date of Event
    December 1, 1996
    Report Date
    January 9, 1997
    Manufacturer
    DAVOL INC.
    Product Code
    EXF
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE BILE BAG WAS IMPROPERLY MFG. THE DRAINAGE END OF THE BAG WITH FLUTTER VALVE WAS CONNECTED TO THE BOTTOM OUTLET WHICH WOULDN'T ALLOW COMPLETE DRAINAGE. NORMALLY THE VALVE IS AT THE TOP OF THE BAG WITH CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILE BAG REGULAR BILE DRAINAGE BAG EXF DAVOL INC. * 76KF2130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other G.| RECEIVED TWO BAGS WITH DEFECTS NURSE THREW AWAY BA