BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML SYRINGE 22G X 1 RP

    MDR report key: 16637657 · Received March 29, 2023

    Report

    Report Number
    1017768-2023-01049
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 28, 2023
    Report Date
    August 28, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    20884521012711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE TO US, WE WERE ABLE TO CONFIRM THE EVENT, AND DETERMINED THAT: THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. FIVE UNUSED SAMPLES WERE RETURNED FOR EVALUATION AND THE REPORTED ISSUE WAS SEEN DURING VISUAL EVALUATION. A REVIEW OF ALL AVAILABLE INFORMATION WAS UNABLE TO DETERMINE AN EXACT ROOT CAUSE. NO CORRECTIVE ACTIONS REQUIRED AT THIS TIME. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER 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 IT LOOKS LIKE THE RUBBER PLUNGERS MELTED OR SOMETHING. WHEN THEY TRIED TO PULL UP A VACCINE THE CONTENTS DRIPPED OUT OF THE PLUNGER SIDE OF THE SYRINGE. THEY KIND OF LOOKED FLIPPED TO THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087559 3ML SYRINGE 22G X 1 RP SYRINGE, PISTON FMF CARDINAL HEALTH 8881513231 22L052 20884521012711

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown