BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 8632278 · Received May 22, 2019

    Report

    Report Number
    3002682307-2019-00323
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903019489
    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

    INVESTIGATION: BD HAS BEEN PROVIDED WITH SAMPLE FOR CATALOG 301948 LOT 1811160 TO INVESTIGATE FOR THIS RECORD. AFTER EVALUATION OF THE RETURNED SAMPLE, THE FOREIGN MATTER WAS IDENTIFIED AS EMBEDDED CONTAMINATION IN THE BARREL. 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 A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE BARREL WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE USE, IT WAS FOUND BLACK FOREIGN MATTER IN BARREL." 7 OCCURRENCES WERE REPORTED, NO DATE/TIME OR PATIENT INFORMATION GIVEN.

    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 FOREIGN MATTER OCCURRED WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE USE, IT WAS FOUND BLACK FOREIGN MATTER IN BARREL." 7 OCCURRENCES WERE REPORTED, NO DATE/TIME OR PATIENT INFORMATION GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427879 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1811160 00382903019489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other