BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY BLOOD COLLECTION SET

    MDR report key: 12331373 · Received August 17, 2021

    Report

    Report Number
    8020040-2021-00031
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Report Date
    August 17, 2021
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K121908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATEMENT (B)(4): NO MATERIAL NUMBER WAS PROVIDED BY THE CUSTOMER. NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. ACCORDING TO THE CUSTOMER, THERE WAS NO MALFUNCTION. THE COMPLAINT IS NOT JUSTIFIED.

    Description of Event or Problem · 1

    CUSTOMER STATES INCREASE IN NEEDLE STICK INJURIES SINCE IMPLEMENTATION OF GREINER BUTTERFLY NEEDLES AT THEIR FACILITY. CUSTOMER REQUESTED FROM ACCOUNT MANAGER TO SEND EDUCATION TEAM (PRODUCT SPECIALISTS) TO TRAIN CLINICAL STAFF TO PREVENT MORE INJURIES. GBO PRODUCT SPECIALIST ADVISED THAT THERE HAS BEEN TWO NEEDLE STICKS IN THE LAB FROM ONE MALE PHLEBOTOMIST. THEY USE THE SBCSS DEVICES (NOT EVOPROTECT]. GBO PRODUCT SPECIALIST WAS ONSITE (B)(6) 2021 TO PERFORM TRAINING AS REQUESTED BY CUSTOMER. AFTER SITE VISIT, GBO PRODUCT SPECIALIST ADVISED THAT THE EMPLOYEE HEALTH SERVICES NEEDLESTICK PERSON IS NOT ONSITE THIS WEEK AND THERE ARE NOT ANY DEVICES LEFT FROM THE INCIDENTS (NO PRODUCT OF LOT AFFECTED AVAILABLE FOR RETURN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231930 SAFETY BLOOD COLLECTION SET FMI GREINER BIO-ONE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1