BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T BNS

    MDR report key: 19894568 · Received August 2, 2024

    Report

    Report Number
    1213809-2024-00513
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    June 19, 2024
    Report Date
    February 21, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010252
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE AFTER THE MDR WAS SUBMITTED, PLEASE REFER TO (B)(4).

    Additional Manufacturer Narrative · 0

    THREE PHOTOS OF 1ML LUER-SLIP SYRINGES (P/N - 301025) WERE RECEIVED AND EVALUATED. THE THREE IMAGES RECEIVED EACH SHOW LOOSE SYRINGES THAT HAVE A SLIGHT DISCOLORATION ON THE BARREL TIP WHICH DOES NOT AFFECT FORM, FIT OR FUNCTION: THEREFORE, ARE ACCEPTABLE. NO EXCESS OR DRIED SILICONE WAS OBSERVED. 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 NUMBERS 3241635 AND 3241633. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. 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 WAS PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL: 301025 BATCH#: 3241635, 3241633 . IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T BNS HAD SILICONE VISIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ALL THE MATERIAL THAT WE HAVE IN STOCK OF THE ITEM 301025 (K-08800-004A) HAVE BEEN REJECTED. THE REASON OF THIS REJECTION IS BECAUSE THE MATERIAL CONTAINS EXCESS OF SILICONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400166 BD SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3241633 50382903010252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown