BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2EDTA TUBE WITH A PINK BD HEMOGARD¿

    MDR report key: 7079971 · Received December 4, 2017

    Report

    Report Number
    1917413-2017-00190
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    August 26, 2015
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A SAMPLE WAS SENT TO BDJ FOR EVALUATION. BDJ DID CONFIRM VIA AIR LEAK OUT BOTTOM OF TUBE. A PHOTO WAS RETURNED AND SHOWED THE CUSTOMERS INDICATED FAILURE OF LEAKAGE FROM DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5041989. CONCLUSION: CONFIRMED COMPLAINT. DEFECT IS CALLED A DOUBLE SHOT DEFECT FROM PLASTIC MOLDING ON BOTTOM OF TUBE AND IS BEING RELATED TO MANUFACTURING PROCESS. THE MOST LIKELY ROOT CAUSE FOR THIS IS A PART STICKING TO THE MOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2 ML, 13 MM X 75 MM BD VACUTAINER® K2EDTA TUBE WITH A PINK BD HEMOGARD¿ HAD A SMALL DEFECT THAT CAUSED LEAKAGE ON THE BOTTOM OF TUBE. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858805 BD VACUTAINER® K2EDTA TUBE WITH A PINK BD HEMOGARD¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5041989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other