BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 22159497 · Received June 6, 2025

    Report

    Report Number
    9614033-2025-00051
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    April 23, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903046560
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THREE PHOTOS AND ONE PHYSICAL SAMPLE WERE RECEIVED BY OUR QUALITY TEAM. IN THE PHOTOS AND PHYSICAL SAMPLE, IT WAS OBSERVED THAT THE TIP OF THE SYRINGE IS DAMAGED; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE THE DAMAGE TO THE LUER TIP OCCURRED DURING THE MANUFACTURING PROCESS. ACTIONS HAVE BEEN PUT IN PLACE TO MITIGATE THIS DEFECT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304656, BATCH # 4193536. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RECEIVED A PRODUCT QUALITY COMPLAINT RELATED TO PRODUCT(S) MANUFACTURED AT YOUR FACILITY. BASED ON THE COMPLAINT INFORMATION PROVIDED WITHIN THIS EMAIL NOTIFICATION, PLEASE REVIEW THE BELOW QUALITY RECORDS AND ANY APPLICABLE RETAIN SAMPLES, TO SUPPORT THE ONGOING INVESTIGATION. PLEASE COMPLETE THE BELOW CHECKLIST AND PROVIDE INVESTIGATION DETAILS WITHIN 15 DAYS. IF ADDITIONAL TIME IS NEEDED TO PERFORM THE INVESTIGATION, PLEASE PROVIDE JUSTIFICATION FOR EXTENSION AND ESTIMATED COMPLETION DATE. COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: 153245 (DNQSYRINGE 5ML LL BNS) VENDOR PART NO 304656. PRODUCT LOT NUMBER: 4193536. COMPLAINT DETAILS: ¿DATE OF EVENT 4/23/2025. ACCORDING TO THE FACILITY ON 04/23/2025 THE 5 ML SYRINGE "EXPERIENCED LEAKING AFTER THE MEDS WERE PUT IN". PER THE FACILITY "THERE IS A SMALL DEFECT ON THE TIP OF THE SYRINGE THAT LOOKS LIKE IT MELTED". PER THE FACILITY "THE LEAKING OCCURRED AFTER IT WAS FILLED WITH MEDS AND TRYING TO INJECT". PER THE FACILITY THERE WAS NO PATIENT INVOLVEMENT, AND NO INJURY REPORTED.¿ ACCOUNT HAD 5 DIFFERENT INCIDENTS INVOLVING THE 5ML SYRINGES THEREFORE FIVE COMPLAINTS WERE CREATED. SAMPLE IS AVAILABLE & PICTURE AVAILABLE PLEASE ADVISED NEXT STEPS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718773 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193536 00382903046560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown