BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE SOLOMED 2PC

    MDR report key: 18253301 · Received December 2, 2023

    Report

    Report Number
    3002682307-2023-00348
    Event Type
    Malfunction
    Date Received
    December 2, 2023
    Date of Event
    September 15, 2023
    Report Date
    January 10, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    30382903027720
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO SIGNS OF DEFECT WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE SOLOMED 2PC HAD A PACKAGING BREECH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BROKEN SYRINGE PACKAGING WAS FOUND BEFORE THE CHILD WAS ADMINISTERED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504276 BD SYRINGE SOLOMED 2PC NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 2110403 30382903027720

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown