BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9959762 · Received April 14, 2020

    Report

    Report Number
    3002682307-2020-00132
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    February 18, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901166. THE REVIEW REVEALED ONE QUALITY NOTIFICATION DURING THE PRODUCTION PROCESS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. THIS QUALITY ISSUE WAS HANDLED DURING THE TIME OF PRODUCTION. DURING THE PRODUCTION OF THE PRODUCT, EMBEDDED MATERIAL WAS FOUND WITHIN THE BARREL COMPONENT. SOME PARTICLES MAY RESIDE IN THE WALLS OF THE PRODUCT MOLD AND DUE TO THE HIGH WORKING TEMPERATURES, THE PARTICLES BURN. IT IS POSSIBLE THAT THESE PARTICLES THEN BECOME EMBEDDED INTO THE MOLDED PIECE. AS A SAMPLE WAS NOT AVAILABLE FOR RETURN, IT CANNOT BE CONFIRMED THAT THIS IS THE EXACT CASE OF FOREIGN MATTER. IF THIS INCIDENT IS RELATED TO THE BURNT PARTICLES WITHIN THE MOLDING MACHINE, IT IS A COSMETIC DEFECT ONLY, AS THE PLASTIC PIECE IS EMBEDDED WITH NO CHANCE OF DETACHMENT. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO REDUCE THE RISK OF THIS INCIDENT FROM RECURRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 5ML 22GA 1-1/4IN BD EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE OPENED THE SYRINGE AND FOUND A FOREIGN MATTER IN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE S2 5ML 22GA 1-1/4IN BD EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE OPENED THE SYRINGE AND FOUND A FOREIGN MATTER IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422035 SYRINGE S2 5ML 22GA 1-1/4IN BD SYRINGE FMF BECTON DICKINSON, S.A. 1901166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other