BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE

    MDR report key: 2033245 · Received March 24, 2011

    Report

    Report Number
    2033245
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AMNISURE INTERNATIONAL LLC
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS ATTEMPTING TO TEST FOR FETAL MEMBRANE RUPTURE USING AMNISURE TEST KIT. VIAL SHOULD HAVE CONTAINED SOLVENT WAS EMPTY. NURSE OBTAINED ANOTHER AMNISURE TEST KIT FROM THE SAME BOX AS FIRST KIT (LOT NUMBER THE SAME) AND SUCCESSFULLY COMPLETED TEST. THERE WAS SLIGHT DELAY IN TESTING.====================== MANUFACTURER RESPONSE FOR FETAL MEMBRANE RUPTURE TEST KIT, AMNISURE======================FILED COMPLAINT BY TELEPHONE; COMPANY ACKNOWLEDGED THAT THIS ISSUE HAS ARISEN FROM TIME TO TIME. THEY ARE IN PROCESS OF IMPLEMENTING A CHANGE TO A DIFFERENT VIAL THAT WILL PROVIDE BETTER SEAL.============== REPORTER RESPONSES ======================REPORTER INDICATED THE KIT IS INDIVIDUALLY PACKAGED AND SEALED IN A PLASTIC BAG. NO MOISTURE OR MOISTURE STAINS WERE NOTED. THE USER FACILITY HAD A SIMILAR INCIDENT ABOUT TWO MONTHS AGO. NO VISUAL DISCREPANCIES WERE NOTED ON THE VIAL. MANUFACTURER REPRESENTATIVE ADMITTED TO THE USER FACILITY THEY ARE AWARE OF THE PROBLEM AND THEY ARE WORKING TOGETHER WITH FDA ON A NEW VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMNISURE FETAL MEMBRANE RUPTURE TEST KIT NQM AMNISURE INTERNATIONAL LLC * A0012

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR