BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9174551 · Received October 10, 2019

    Report

    Report Number
    3002682307-2019-00544
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED A SAMPLE FOR CATALOG 301942 LOT 1811195 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE IDENTIFIES SMALL DOTS AS EMBEDDED CONTAMINATION IN THE BARREL. AS A RESULT, BD WAS ABLE TO 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), SOME PARTICLES OF PLASTIC AND REST OF OIL FROM THE POLYPROPYLENE CAN REMAIN STUCK ON THE INTERNAL WALLS OF THE MOLD AND GET BURNT. DURING NORMAL PRODUCTION SOME PARTICLE MAY BE DETACHED FROM THE SCREW BEING INJECTED AND REMAINING EMBEDDED IN MOLDED PIECE. THIS IS 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. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE S2 5ML 22GA 1-1/4IN THERE WAS AN ISSUE WITH BLACK FOREIGN MATTER INSIDE THE SYRINGE. SEVEN SYRINGES WERE FOUND WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON SEPTEMBER 25, 2019, RECEIVED AN EMERGENCY DEPARTMENT FROM THE (B)(6) HOSPITAL OF (B)(6). FOUND A BLACK FOREIGN MATTER INSIDE THE 5 ML 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 BEFORE USE OF THE SYRINGE S2 5ML 22GA 1-1/4IN THERE WAS AN ISSUE WITH BLACK FOREIGN MATTER INSIDE THE SYRINGE. SEVEN SYRINGES WERE FOUND WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6) 2019, RECEIVED AN EMERGENCY DEPARTMENT FROM (B)(6). FOUND A BLACK FOREIGN MATTER INSIDE THE 5 ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971944 SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1811195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other