BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® QUICKSHIELD SAFETY VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4"

    MDR report key: 17391108 · Received July 25, 2023

    Report

    Report Number
    8020040-2023-00012
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Report Date
    July 25, 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 (B)(4) PCS 450062/21J22C. WE HAVE NO REMAINING INVENTORY OF THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. THE CUSTOMER DID NOT ALLEGE A PRODUCT MALFUNCTION/DEFICIENCY. THE COMPLAINT IS CLOSED AS NOT JUSTIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER STATES DIRTY NEEDLESTICK OCCURRED WHEN THE NEEDLE DIDN'T CLICK WHEN FIRST ACTIVATED AND CAME OUT OF THE SAFETY DEVICE AND WENT THROUGH THE SIDE OF THE GUARD. THE EVENT DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. EVENT DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698022 VACUETTE® QUICKSHIELD SAFETY VACUETTE® MULTIPLE USE DRAWING NEEDLE 21G X 1 1/4" BLOOD COLLECTION NEEDLE FMI GREINER BIO-ONE GMBH 450062 21J22C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown