BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2

    MDR report key: 14778103 · Received June 22, 2022

    Report

    Report Number
    3014312726-2022-00005
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 11, 2022
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    10884521544796
    PMA / PMN Number
    K123684
    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 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G X ½", REF 11812705, LOT 01107028 WITH NO ANOMALIES FOUND ON BATCH DOCUMENTATION. NO SAMPLES WERE RECEIVED BY THE CUSTOMER FOR EVALUATION. ARCHIVE SAMPLE EVALUATION: VISUAL CHECK: 50PCS HAVE BEEN VISUALLY CHECKED WITH NO LOOSEN NEEDLE OR DETACHED NEEDLE FOUND. SIMULATION TEST: 10PCS HAVE BEEN TESTED BY WITHDRAWING AND EJECTING WATER FROM THE SYRINGE AND FINALLY ACTIVATING THE SAFETY MECHANISM. NO DIFFICULTY IN THE WITHDRAWAL OF WATER INTO THE SYRINGE, NO DETACHED NEEDLES WERE FOUND. RESISTANCE TO SEPARATION FROM AXIAL LOAD TEST: 5PCS HAVE BEEN CHECKED IN ACCORDANCE WITH ISO 80369-20:2015, ANNEX F. ALL SAMPLES TESTED PASSED THE TEST. RESISTANCE TO SEPARATION FROM UNSCREWING TEST: 5PCS HAVE BEEN CHECKED IN ACCORDANCE WITH ISO 80369-20:2015, ANNEX G. ALL SAMPLES TESTED PASSED THE TEST. RESISTANCE TO OVERRIDING TEST: 5PCS HAVE BEEN CHECKED IN ACCORDANCE WITH ISO 80369-20:2015, ANNEX H. 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

    CUSTOMER REPORTS: WHEN THE PHYSICIAN USED A TB NEEDLE/SYRINGE TO INJECT A LOCAL ANESTHETIC ON AN INFANT, IT WAS DIFFICULT TO DRAW UP THE MEDICATION. THERE WERE MULTIPLE ATTEMPTS MADE TO FILL THE SYRINGE AND DRAW UP THE MEDICATION. WHEN REMOVING AIR FROM THE SYRINGE, THE NEEDLE PORTION FELL OFF THE SYRINGE. THE INTENDED PROCEDURE: WAS TO ADMINISTER LOCAL ANESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958979 MONOJECT 1ML SYRINGE W/HYPODERMIC SAFETY NEEDLE 27G*1/2 HYPODERMIC NEEDLE FMI SOL-MILLENNIUM MEDICAL INC. 11812705 01107028 10884521544796

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown