BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN

    MDR report key: 18238600 · Received November 30, 2023

    Report

    Report Number
    3002682307-2023-00344
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    May 12, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE: A020504 - TEAR, RIP OR HOLE IN DEVICE PACKAGING PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT PR 9202479: INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302772 AND LOT NUMBER 2110403. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. AT THIS TIME, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    BROKEN SYRINGE PACKAGING WAS FOUND BEFORE THE CHILD WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136389 SYRINGE SOLOMED 2PC 2ML 25X5/8 FIXED CN SYRINGE, PISTON FMF BECTON DICKINSON 2110403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown