BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.25 X 64MM, 3.0ML BD VACUTAINER® ACD GLASS TUBE

    MDR report key: 6609515 · Received June 2, 2017

    Report

    Report Number
    1917413-2017-00015
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    February 8, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5120609. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO INCIDENTS WHERE THE YELLOW TOP (STOPPER) OF A 10.25 X 64MM, 3.0ML BD VACUTAINER® ACD GLASS TUBE CAME OFF DURING BLOOD COLLECTION. THIS CAUSED BLOOD TO SPLATTER ON THE COLLECTOR'S GLOVED HANDS. SPECIMEN TUBES WERE COLLECTED USING SINGLE USE HOLDERS WITHOUT THE PEDIATRIC TUBE ADAPTERS. THERE WAS NO REPORT OF BLOOD EXPOSURE TO MUCOSAL MEMBRANES, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388249 10.25 X 64MM, 3.0ML BD VACUTAINER® ACD GLASS TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5120609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other