BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿

    MDR report key: 7085804 · Received December 5, 2017

    Report

    Report Number
    9617032-2017-00313
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    September 1, 2016
    Report Date
    November 24, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A PHOTO WAS ATTACHED SHOWING THE TOP OF A TUBE, WITH BLOOD POOLED IN THE CENTER OF ITS STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6011665. 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 A BD VACUTAINER® BARRICOR¿ HAD BLOOD POOLING IN THE CAP. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863559 BD VACUTAINER® BARRICOR¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6011665

    Patients

    Seq Age Sex Outcome Treatment
    1 Other