BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE, GOLD BD HEMOGARD¿ CLOSURE

    MDR report key: 7072789 · Received November 30, 2017

    Report

    Report Number
    1024879-2017-00835
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    August 4, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE OR PHOTO WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6120706. CONCLUSION: UNCONFIRMED. 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 THE HEMOGARD CAP OF THE 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE WITH THE GOLD BD HEMOGARD¿ CLOSURE, CAME OFF DURING CENTRIFUGATION, EXPOSING CHEMISTRY STAFF TO BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852254 BD VACUTAINER® PLUS PLASTIC SST TUBE, GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 6120706 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other