BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP WITH INTEGRATED SAMPLING DEVICE

    MDR report key: 5210728 · Received November 9, 2015

    Report

    Report Number
    1917413-2015-00001
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 15, 2015
    Report Date
    November 6, 2015
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    OIE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- A SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION- WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LAB TECH RECEIVED A SAMPLE IN A BD VACUTAINER PLASTIC URINE COLLECTION CUP. THE DEVICE'S LID WAS WRAPPED WITH PARAFILM TO PREVENT LEAKING AND THE PROTECTIVE COVER ON THE NEEDLE WAS NOT IN PLACE. AS THE TECH WAS TRYING TO REMOVE THE LID FROM THE CUP, THE INDEX FINGER OF HIS LEFT HAND WENT INSIDE THE LID RECEPTACLE AND HE STUCK HIMSELF ON THE NEEDLE. HE WAS EVALUATED FOR BLOODBORNE PATHOGENS. THE SOURCE PATIENT WAS SEEING AN INFECTIOUS DISEASE DOCTOR FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742379 BD VACUTAINER® PLASTIC URINE COLLECTION CUP WITH INTEGRATED SAMPLING DEVICE COLLECTION CUP OIE BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other