BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT/CHILD LUMBAR 22G 1 1/2 NDL

    MDR report key: 350439 · Received August 31, 2001

    Report

    Report Number
    1018381-2001-00073
    Event Type
    Malfunction
    Date Received
    August 31, 2001
    Date of Event
    July 16, 2001
    Report Date
    August 1, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    IQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN UNDOCUMENTED NUMBER OF UNDOCUMENTED INCIDENTS OF THE COLLECTION TUBE LEAKING. THE CUSTOMER REPORTS THAT VIRAL CULTURES ARE SENT TO AN OFF-SITE LABORATORY. THE TUBES ARE PUT INTO A TRANSPORT BAG AND COOLER. WHEN THE TUBES ARRIVE AT THE OFF-SITE LAB IT HAS BEEN REPORTED THAT THE FLUID HAS LEAKED OUT OF THE TUBE AND INTO THE BAG. THE TUBES ARE INTACT AND THE LIDS ARE INTACT, BUT THE FLUID IS IN THE BAG. THERE HAVE BEEN REPORTS WHERE SOME OF THE PATIENTS HAVE NEEDED TO BE RE-STUCK FOR ADDITIONAL SPECIMEN COLLECTION. THERE HAVE BEEN NO REPORTS OF ADVERSE PATIENT EVENTS. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39662 INFANT/CHILD LUMBAR 22G 1 1/2 NDL PROCEDURAL TRAY IQE ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other