BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 10795516 · Received November 5, 2020

    Report

    Report Number
    8020040-2019-00016
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    GREINER BIO-ONE GMH
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). NO SAMPLES (ACTUAL OR UNUSED) WERE PROVIDED BY THE CUSTOMER. CUSTOMER PICTURES RECEIVED. NO MATERIAL#(S) NOR BATCH#(S) WERE PROVIDED BY THE CUSTOMER. NO CLARIFICATION OR FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER. UNFORTUNATELY, WITHOUT BASIC INFORMATION, A THOROUGH INVESTIGATION IS NOT POSSIBLE. WE HAVE FORWARDED THE COMPLAINT AND CUSTOMER PICTURES TO OUR AFFILIATED HEADQUARTERS AND SUPPLIER FOR THEIR INFORMATION. THIS COMPLAINT IS CLOSED AS CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER SUBMITTED PHOTO SHOWING A BENT NEEDLE. NO INFORMATION WAS GIVEN AS TO HOW THE NEEDLE BECAME BENT. CUSTOMER SUBMITTED PHOTO SHOWING A NEEDLE THAT BECAME DISLODGED FROM THE HOLDER. NO INFORMATION WAS GIVEN AS TO HOW THE NEEDLE BECAME DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254863 UNKNOWN CANNULA FMI GREINER BIO-ONE GMH UNKNOWN NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1