BEUDAMED
    FDA Adverse Event Summary report: N

    MEDMATE PUMP SET

    MDR report key: 12876 · Received April 21, 1994

    Report

    Report Number
    MW1001683
    Date Received
    April 21, 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 PROFUSE LEAK OF IV FLUIDS FROM THE LUER CONNECTOR. DID NOT APPEAR TO BE THE RESULT OF EXCESSIVE PRESSURE IN MAKING THE CONNECTION. THERE WAS NOT A "CRACK." SECOND OCCURRENCE WITH THIS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *