BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY BLOOD COLLECTION SETS

    MDR report key: 20256421 · Received September 19, 2024

    Report

    Report Number
    8020040-2024-00006
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Report Date
    September 19, 2024
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K121908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). NO SAMPLES WERE PROVIDED BY THE CUSTOMER. NO MATERIAL NUMBERS WERE PROVIDED BY THE CUSTOMER. NO BATCH NUMBERS WERE PROVIDED BY THE CUSTOMER. NO FURTHER INFORMATION OR CLARIFICATION WAS PROVIDED BY THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE.THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    UC HEALTH ADVISED THEY HAD 13 DIRTY NEEDLESTICK INJURIES (ONLY LAB EMPLOYEES) USING THE BUTTERFLIES DURING THE CONVERSION. THIS WAS THE FIRST TIME THE STATEMENT WAS MADE BY THE UC HEALTH SITE. CUSTOMER RESPONDED THAT ALL 13 NEEDLESTICK INCIDENTS DID NOT CAUSE ANY SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489190 SAFETY BLOOD COLLECTION SETS SAFETY BLOOD COLLECTION SYSTEM FMI GREINER BIO-ONE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown