BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER

    MDR report key: 13542168 · Received February 16, 2022

    Report

    Report Number
    3007817041-2022-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Report Date
    March 18, 2022
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K033478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE RECEIVED AND FORWARDED TO THE SUPPLIER WHERE WE PURCHASE THE ITEM FROM. AS SOON AS THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED 21PCS 450230/G210934L FOR EVALUATION. NO CUSTOMER PICTURES WERE PROVIDED. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND SAMPLES TO OUR AFFILIATED HEADQUARTERS IN AUSTRIA FROM WHICH WE RECEIVE THIS PRODUCT. ACCORDING TO THEIR INVESTIGATION AND COMMENTS, A REVIEW OF PRODUCTION DOCUMENTATION REVEALED NO DEVIATIONS RELATED TO THE REPORTED BATCH. CUSTOMER SAMPLES WERE CHECKED VISUALLY. THE VISUAL INSPECTION REVEALED NO DEVIATIONS RELATED TO THE COMPLAINED ERROR. SCREWING-IN TORQUE, SPIN-OUT, AND PULL FORCE WERE THEN FUNCTIONALLY CHECKED. DURING THESE PERFORMED TESTS, NO IRREGULARITIES COULD BE DETECTED. THE ALLEGED MALFUNCTION CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER STATES NEEDLESTICK OCCURRED. A PSR RECEIVED A NEEDLESTICK USING A GREINER STRAIGHT NEEDLE, SHE STATED AS SHE WENT TO ENGAGE THE SAFETY THAT IT FELT LOOSE AND/OR FLIMSY, IT DID NOT ENGAGE PROPERLY AND "BENT TO THE SIDE" IN HER WORDS. BLOOD EXPOSURE QUESTIONS SUBMITTED. THE USED NEEDLE WAS ITEM/LOT IS 450062, 21E31C, B21054FJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940979 VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER SAFETY TUBE HOLDER FMI GREINER BIO-ONE GMBH 450230 G210934L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown