BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION TUBE

    MDR report key: 7067437 · Received November 29, 2017

    Report

    Report Number
    1917413-2017-00238
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    August 15, 2015
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    UDI-DI
    00382903649792
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE DEVICE TYPE CODE AS JSM. IT IS CORRECTED TO READ KDT. THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS N/A. IT IS CORRECTED TO READ EXEMPT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION, BULK TUBE, 10 ML, 16 X 100 MM HAD URINE SPILLING AND SPLASHING ON THE RACKS AS THEY WERE ON THE RACKS AND AS IT TRAVELS INTO ANALYZER FOR TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848916 BD VACUTAINER® URINE COLLECTION TUBE URINE COLLECTION SET KDT BECTON, DICKINSON & CO. UNKNOWN 00382903649792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other