BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE

    MDR report key: 17282706 · Received July 7, 2023

    Report

    Report Number
    8020040-2023-00009
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K973620
    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 STATEMENT (B)(4): RECEIVED 100PCS OF 450062/21L04C. WE HAVE NO FURTHER INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT TO OUR SUPPLIER FOR THEIR INFORMATION. THE CUSTOMER DID NOT ALLEGE A PRODUCT MALFUNCTION/DEFICIENCY. THEREFORE, THE COMPLAINT IS CLOSED AS NOT JUSTIFIED.

    Description of Event or Problem · 0

    CUSTOMER STATES NEEDLESTICK OCCURRED. PHLEBOTOMIST WAS ATTEMPTING A BLOOD DRAW AND THE SAFETY CAP POPPED OFF. PHLEBOTOMIST ATTEMPTED TO PLACE THE SAFETY BACK ON THE HOLDER AND WAS STUCK WITH THE NEEDLE IN HER THUMB. WHEN THE ACCOUNT RECEIVES THE HOLDERS, BAGS THEY COME IN CONTAIN AT LEAST 13 OF THE CAPS OFF THE HUBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056475 VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" GREEN, STERILE NEEDLES FMI GREINER BIO-ONE GMBH 450062 21L04C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown