BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7067525 · Received November 29, 2017

    Report

    Report Number
    1917413-2017-00249
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    September 8, 2015
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903697144
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PHOTO SAMPLES WERE RECEIVED AND EVALUATED SHOWING DEFECT. A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5041596. CONCLUSION: 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 13 X 75 MM X 4.5 ML BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿BROKE WHILE PHLEBOTOMIST WAS COLLECTING BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848978 BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5041596 00382903697144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other