BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION, BULK TUBE, 8.0 ML 16X100 MM

    MDR report key: 7006992 · Received November 7, 2017

    Report

    Report Number
    1917413-2017-00227
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    January 25, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWED THE REPORTED DEFECT. 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.

    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 THE BD VACUTAINER® URINE COLLECTION, BULK TUBE, 8.0 ML 16X100 MM WAS MISSING A LABEL ON A TUBE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785451 BD VACUTAINER® URINE COLLECTION, BULK TUBE, 8.0 ML 16X100 MM URINE COLLECTION SYSTEM KDT BECTON, DICKINSON & CO. UNKNOWN 00382903649921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other