BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE

    MDR report key: 2210985 · Received August 10, 2011

    Report

    Report Number
    2210985
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    AMNISURE
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS PREPARING TO PERFORM THE TEST AND OBSERVED THAT THE VIAL WAS EMPTY. IT SHOULD HAVE CONTAINED THE DILUENT. THE NURSE OBTAINED ANOTHER TEST KIT (SAME MANUFACTURER AND LOT NUMBER) WHICH HAD A VIAL THAT CONTAINED DILUENT.THIS HAS BEEN A RECURRING PROBLEM. WE HAVE BEEN IN COMMUNICATION WITH THE VENDOR. THE VENDOR INDICATED THAT THEY HAVE MADE A CHANGE IN MANUFACTURING AND NOW THE VIAL IS SEALED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES