BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML SYRINGE 22G X 1 RP

    MDR report key: 17919687 · Received October 12, 2023

    Report

    Report Number
    1017768-2023-01094
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 25, 2023
    Report Date
    August 8, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    20884521012711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DEVICE WAS MANUFACTURED BETWEEN 05/10/2023 AND 05/15/2023. NO SAMPLES WERE RECEIVED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION THE REPORTED CONDITION COULD NOT BE CONFIRMED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT IT HAS A BENT AND CAN'T PULL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132791 3ML SYRINGE 22G X 1 RP SYRINGE, PISTON FMF CARDINAL HEALTH 8881513231 23E279 20884521012711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown