BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE

    MDR report key: 7070465 · Received November 30, 2017

    Report

    Report Number
    1917413-2017-00247
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    January 29, 2016
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903630837
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SAMPLES WERE RETURNED FOR EVALUATION, DRAW TESTED, TUBES WERE WITHIN SPECIFIC LIMITS WITH NO PULL OUT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5210958. CONCLUSION: 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, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBES CAP CAME OFF WHEN THE PHLEBOTOMIST WITHDREW TUBE FROM HOLDER. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852629 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5210958 00382903630837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other