BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿

    MDR report key: 7085787 · Received December 5, 2017

    Report

    Report Number
    9617032-2017-00318
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    September 1, 2016
    Report Date
    November 25, 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 SAMPLE WAS NOT RETURNED FOR EVALUATION. 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 BD VACUTAINER® BARRICOR¿ HAD BLOOD POOL IN THE WELL OF THE STOPPER AND ONCE IT SPLATTERED EVERYWHERE AFTER TAKING THE TUBE OFF THE VACUTAINER HOLDER. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862478 BD VACUTAINER® BARRICOR¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6011665

    Patients

    Seq Age Sex Outcome Treatment
    1 Other