BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT HYPODERMIC SAFETY NEEDLE 25G*5/8"

    MDR report key: 14775308 · Received June 22, 2022

    Report

    Report Number
    3014312726-2022-00004
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 13, 2022
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    10884521544710
    PMA / PMN Number
    K101359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS NOT TO BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE PRODUCTION SITE CHECKED THE BATCH RECORD OF IMPACTED MONOJECT HYPODERMIC SAFETY NEEDLE 25G X 5/8", REF 1182558, LOT: 02102036 WITH NO ANOMALIES FOUND ON BATCH DOCUMENTATION. NO SAMPLES WERE RECEIVED BY THE CUSTOMER FOR EVALUATION. ARCHIVE SAMPLE EVALUATION: 50PCS OF ARCHIVE SAMPLES HAVE BEEN VISUALLY CHECKED WITH NO ANOMALIES FOUND ON THE NEEDLE HUB. 5PCS OF ARCHIVE SAMPLES HAVE BEEN CHECKED IN ACCORDANCE WITH ISO 80369-20:2015, ANNEX E. ALL SAMPLES TESTED PASSED THE TEST. RISK STATEMENT: THE OVERALL RISK ASSESSMENT, GIVEN THE SEVERITY ASSESSMENT OF S3-MODERATE INJURY AND A PROBABILITY ASSESSMENT OF P2-LOW, THE FINAL RISK PRIORITY NUMBER IS 6. RISK LEVEL IS IN GREEN AREA/LOW RISK ACCORDING TO OUR RISK MANAGEMENT PROCEDURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SIDE OF THE ORANGE NEEDLE HAD A SLIGHT SPLIT IN THE PLASTIC RESULTING IN TREATMENT BEING LEAKED ONTO THE NURSE ADMINISTERING IT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957870 MONOJECT HYPODERMIC SAFETY NEEDLE 25G*5/8" HYPODERMIC NEEDLE FMI SOL-MILLENNIUM MEDICAL INC. 1182558 02102036 10884521544710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown