BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

    MDR report key: 10011939 · Received April 29, 2020

    Report

    Report Number
    3002682307-2020-00138
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 9, 2020
    Report Date
    May 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER 1811191 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, BLACK PARTICLES WERE OBSERVED EMBEDDED WITHIN THE NEEDLE SHIELD. THE EMBEDDED PARTICLES RESULTED FROM A DEFECT IN THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES, IF THE HEAT IS NOT EXPELLED PROPERLY, THE PRODUCT AND RESIDUE CAN BURN WITHIN THE MOLDING CAVITY. THIS IS A COSMETIC DEFECT WITHOUT THE POSSIBILITY OF DETACHMENT. AT THIS TIME, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD FOREIGN MATTER ON THE CAP OF THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LARGE NUMBER OF BLACK AND YELLOW SPOTS WAS FOUND ON THE NEEDLE CAP OF THE SYRINGE. THIS PROBLEM WAS FOUND DURING THE INSPECTION BEFORE USAGE, AND IT WAS NOT USED. THE DEPARTMENT WAS OBSTETRICS DEPARTMENT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA HAD FOREIGN MATTER ON THE CAP OF THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LARGE NUMBER OF BLACK AND YELLOW SPOTS WAS FOUND ON THE NEEDLE CAP OF THE SYRINGE. THIS PROBLEM WAS FOUND DURING THE INSPECTION BEFORE USAGE, AND IT WAS NOT USED. THE DEPARTMENT WAS OBSTETRICS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476042 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other