BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BARRICOR¿ 13X100, 4.5 ML TUBE

    MDR report key: 7077345 · Received December 1, 2017

    Report

    Report Number
    9617032-2017-00277
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    June 30, 2016
    Report Date
    November 4, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K160657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6011665. PHOTOS WERE EVALUATED AND SHOW WHAT APPEARS TO BE BLOOD POOLING IN THE STOPPER. HOWEVER, THERE WERE NO DEFECTS FOUND WITH THE DEVICES SENT BACK. CONCLUSION: 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 WHILE USING THE BD VACUTAINER® BARRICOR¿ 13X100, 4.5 ML TUBE BLOOD POOLED AT TOP OF THE COLLECTION TUBE STOPPER. NO INJURY, BLOOD EXPOSURE, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853324 BD VACUTAINER® BARRICOR¿ 13X100, 4.5 ML TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6011665

    Patients

    Seq Age Sex Outcome Treatment
    1 Other