BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJET SYRINGE

    MDR report key: 12924 · Received April 25, 1994

    Report

    Report Number
    MW1001718
    Event Type
    Malfunction
    Date Received
    April 25, 1994
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER BEING PREFILLED AND STORED IN A FREEZER, SYRINGE PLUNGERS ARE LOSING THEIR SEALS, ALLOWING AIR TO ENTER THE BARREL OF THE SYRINGE. THIS "ROOM AIR" IN TURN CONTAMINATES THE MEDICATION INTENDED FOR IV USE. THE SYRINGE PROGRAM PROVIDES FROZEN STABILITY DATA FOR DRUGS UP TO A YR. SINCE THE SYRINGE PACKS ARE PROMOTED ALONG WITH THE PROGRAM, THE PRODUCT SHOULD SUPPORT THE DATA PROVIDED TO THE CUSTOMER. (ALSO SEE 1001717 AND 1001719.) (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJET SYRINGE SYRINGE FMF SHERWOOD MEDICAL CO. 723860

    Patients

    Seq Age Sex Outcome Treatment
    1 *