BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® GLASS PLASMA TUBE LT. BLUE BD HEMOGARD¿

    MDR report key: 7115162 · Received December 13, 2017

    Report

    Report Number
    1917413-2017-00606
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    December 28, 2016
    Report Date
    December 12, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903697149
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD PAS RECEIVED(B)(4) SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE OF ¿DRAW VOLUME - UNDERFILL¿ AND "SPLIT TUBES" WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. WATER FILL TESTING WAS CONDUCTED ON THE CUSTOMER SAMPLES AND NO DEFECTS RELATED TO DRAW VOLUME WERE OBSERVED. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE CUSTOMER SAMPLES. ONE ROOT CAUSE OF THE DAMAGE THAT IS BETWEEN STOPPER AND THE LABEL IS A J CRACK. IT CAN HAPPEN DURING THE FORMING PROCESS. THIS OCCURS AT THE POINT WHERE THE GLASS IS BEING HEATED TO BE CUT. THE REASON THAT J CRACKS OCCUR IS DUE TO THE QUALITY OF THE CANE GLASS OR IF THE HEAT IS TOO HIGH. IF THE TUBE GETS A J CRACK WHEN THE STOPPER/SHIELD IS ASSEMBLED ONTO THE TUBE IT CAN CAUSE THE TUBE TO BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® GLASS PLASMA TUBE LT. BLUE BD HEMOGARD¿ TUBES HAVE STOPPED FILLING AND TWO HAVE SPLIT IN THE AREA UNDER THE CAP AND ABOVE THE TOP OF THE LABEL. THE TUBES ARE VERY COLD TO TOUCH AND HAVE A LARGER AMOUNT OF "FOGGY AREA" INSIDE THEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891049 BD VACUTAINER® GLASS PLASMA TUBE LT. BLUE BD HEMOGARD¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5272777 50382903697149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other