BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION, BULK TUBE

    MDR report key: 7116910 · Received December 14, 2017

    Report

    Report Number
    1917413-2017-00599
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    February 29, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    UDI-DI
    00382903649921
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS RETURNED AND THE REPORTED DEFECT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5120615. 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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE INCORRECT MEDICAL DEVICE TYPE. THE CORRECT TYPE IS KDT. THE INITIAL MDR WAS SUBMITTED WITH A 510K NUMBER BUT THIS DEVICE IS EXEMPT AND DOES NOT HAVE A 510K ASSOCIATED WITH IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® URINE COLLECTION, BULK TUBE HAD NO LABEL. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898722 BD VACUTAINER® URINE COLLECTION, BULK TUBE URINE COLLECTION SYSTEM KDT BECTON, DICKINSON & CO. 5120615 00382903649921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other