BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8453758 · Received March 26, 2019

    Report

    Report Number
    3002682307-2019-00208
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 A SAMPLE FOR CATALOG 301947, LOT 1810248 TO INVESTIGATE FOR THIS RECORD. AFTER EVALUATION OF THE RETURNED SAMPLE, BD IDENTIFIES THAT THE FOREIGN MATTER PARTICLES ARE A SILICONE OIL MIXED WITH POWDER COMING FROM THE ASSEMBLING PROCESS. AS A RESULT, BD WAS ABLE VERIFY THE REPORTED ISSUE. DUE TO FRICTION BETWEEN PIECES AND MACHINE'S RAILS, LITTLE PLASTIC POWDER IS PRODUCED. THE MIXTURE WAS PRODUCED DUE TO AN ACCUMULATION OF POWDER WHICH MAY DROP OFF DURING SOME UNEXPECTED MOVEMENT IN THE ASSEMBLY MACHINE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE WITH NEEDLE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿AFTER OPENING THE UNIT PACKAGE,THE NEEDLE WITH BLACK FOREIGN MATTER."

    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 BD¿ SYRINGE WITH NEEDLE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿AFTER OPENING THE UNIT PACKAGE,THE NEEDLE WITH BLACK FOREIGN MATTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247409 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1810248

    Patients

    Seq Age Sex Outcome Treatment
    1 Other