BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T BNS

    MDR report key: 19563464 · Received June 18, 2024

    Report

    Report Number
    1213809-2024-00385
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 1, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010252
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FORTY SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED. NO EXCESS OR DRIED SILICONE WAS OBSERVED IN ANY OF THE SAMPLES RECEIVED. ALL SAMPLES HAVE A SLIGHT DISCOLORATION ON THE BARREL TIP WHICH DOES NOT AFFECT FORM, FIT OR FUNCTION. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE THE DEFECTS OBSERVED ARE CONSIDERED COSMETIC AND ACCEPTABLE, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3241635 AND 3241633. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL: 301025 LOT: 3241635 IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T BNS HAD SILICONE VISIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON MAY 27TH 2024, AT BARRANCAS PLANT, DURING THE INCOMING INSPECTION OF MATERIAL K-08800-004A LOT 33P24D0027 QTY (B)(4) EA, IT WAS DETECTED THAT THE MATERIAL CONTAINS EXCESS OF SILICONE. SAMPLE IS 200, REJECT WITH 4 EA AND 45 EA WERE FOUND WITH EXCESS FOR SILICONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780994 BD SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3241633 50382903010252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown