BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE MULT. USE DRAW. NEEDLE 21G X 1"

    MDR report key: 10819878 · Received November 10, 2020

    Report

    Report Number
    8020040-2019-00019
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Report Date
    November 10, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). RECEIVED 12BX + LOOSE PC 450062/18H08C FOR EVALUATION. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIALS/BATCHES. WE FORWARDED THE COMPLAINT AND SOME OF THE SAMPLES TO OUR SUPPLIER FROM WHICH WE RECEIVE THE NEEDLES. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, MANUFACTURING AND INSPECTION RECORDS OF THE CONCERNED MATERIAL/BATCH WERE REVIEWED AND NO ABNORMALITIES WHICH COULD BE RELATED TO THE REPORTED EVENT WERE OBSERVED. RETAIN AND CUSTOMER SAMPLES WERE VISUALLY EXAMINED. NO APPEARANCE DEFECT SUCH AS DAMAGE OR MOLDING DEFECT COULD BE OBSERVED. SAMPLES WERE FUNCTIONALLY CHECKED (WITH GREINER HOLDERS). TEN GREINER BLOOD COLLECTION TUBES WERE INSERTED ONTO EACH TESTED SAMPLE AND NO SPIN-OUT COULD BE OBSERVED. THEY COULD NOT CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT WHEN PHLEBOTOMIST ATTEMPTED TO ENGAGE THE FIRST TUBE, THE HOLDER CAME OFF AND THE NEEDLE REMAINED IN PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285618 VACUETTE MULT. USE DRAW. NEEDLE 21G X 1" CANNULA FMI GREINER BIO-ONE GMBH 450062 18H08C

    Patients

    Seq Age Sex Outcome Treatment
    1