BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE BLOOD COLLECTION NEEDLE

    MDR report key: 13698595 · Received March 8, 2022

    Report

    Report Number
    8020040-2022-00005
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Report Date
    March 8, 2022
    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): A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. NO CUSTOMER SAMPLES WERE RECEIVED. NO MATERIAL OR BATCH NUMBERS WERE RECEIVED. THE CUSTOMER DID NOT ALLEGE A PRODUCT MALFUNCTION/DEFICIENCY. DUE TO INSUFFICIENT INFORMATION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    CUSTOMER ADVISED OF A NEEDLE STICK INJURY. GBO PRODUCT SPECIALIST MANAGER WAS NOTIFIED BY QUEST CUSTOMER SOLUTIONS SPECIALIST AND WAS NOT ABLE TO CONFIRM WHAT DEVICE WAS BEING USED. GBO PRODUCT SPECIALIST MANAGER REQUESTED TRAINING SESSION WITH CUSTOMER AND CLIENT. REQUESTED MORE DETAILED INFORMATION ON THE EVENT, BUT THAT COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168126 VACUETTE BLOOD COLLECTION NEEDLE CANNULA FMI GREINER BIO-ONE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown