BEUDAMED
    FDA Adverse Event Summary report: N

    MEDMATE PUMP SET WITH 100 ML INTERNAL BAG

    MDR report key: 13786 · Received June 6, 1994

    Report

    Report Number
    MW1002356
    Date Received
    June 6, 1994
    Date of Event
    May 18, 1994
    Report Date
    May 26, 1994
    Manufacturer
    PATIENT SOLUTIONS, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DISTAL, WINGED LUER CONNECTOR "PEELED" RESULTING IN LEAK OF IV FLUIDS FROM THE LUER CONNECTOR. THIS IS NOT A "CRACK" IT IS A "PEEL." THIS IS THE SECOND INSTANCE OF THIS PHENOMENA RPTR HAS REPORTED: SEE 1001683. THIS SECOND INSTANCE WAS ON THE SAME PT AS THE FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDMATE PUMP SET WITH 100 ML INTERNAL BAG INFUSION PUMP SET FPA PATIENT SOLUTIONS, INC. D 200B 20914A

    Patients

    Seq Age Sex Outcome Treatment
    1 *