BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8545832 · Received April 24, 2019

    Report

    Report Number
    3002682307-2019-00267
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 29, 2019
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE FOR CATALOG 301942 LOT 1803178 TO INVESTIGATE FOR THIS RECORD. AFTER EVALUATION OF THE RETURNED SAMPLE, THE FOREIGN MATTER WAS IDENTIFIED AS EMBEDDED CONTAMINATION IN THE BARREL. AS A RESULT, BD WAS ABLE VERIFY THE REPORTED ISSUE. THE EMBEDDED PARTICLES DEFECT WAS PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), DIFFERENT GASES ARE PRODUCED INSIDE THE MOLD. DURING NORMAL PRODUCTION THESE GASES ARE EXPELLED THROUGH SOME CONDUITS, OUTSIDE THE MOLD CAVITY. IN THIS CASE THE EXPULSION WAS NOT DONE CORRECTLY AND SOME GASES REMAINED IN THE MOLD CAVITY AND PRODUCE THE BURNT SYRINGE PIECE. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE BARREL OF THE SYRINGE WITHOUT POSSIBILITY OF BEING DETACHED FROM IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT THE BARREL AND FLANGE WITH BLACK FOREIGN MATTER BEFORE USING.

    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 (B)(4) EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT THE BARREL AND FLANGE WITH BLACK FOREIGN MATTER BEFORE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336988 SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1803178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other