BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE WITH GOLD BD HEMOGARD¿

    MDR report key: 7059127 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00269
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 23, 2015
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL SAMPLE NOT RETURNED TO BD, 2 REPRESENTATIVE SAMPLES WERE RETURNED FROM LOT# 5212592 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURING OF THE REPORTED LOT # 5212595. BOTH RETURNED SAMPLES UNDERWENT DRAW TESTING AND PERFORMED MEETING SPECIFIED REQUIREMENTS WITHOUT LEAKAGE AND COULD NOT CONFIRM CUSTOMERS' INDICATED FAILURE MODE OF LEAKAGE. UNCONFIRMED COMPLAINT. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND REPRESENTATIVE SAMPLES SHOWED NO FAILURE MODES, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BLOOD DRAW USING A 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE WITH A GOLD BD HEMOGARD¿ CLOSURE, THE TUBE DIDN'T DRAW BLOOD AND BLOOD ENDED UP GOING INTO THE ADAPTER. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838877 BD VACUTAINER® PLUS PLASTIC SST TUBE WITH GOLD BD HEMOGARD¿ COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5212592 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other