BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BN

    MDR report key: 22097761 · Received May 28, 2025

    Report

    Report Number
    9614033-2025-00044
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 11, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    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

    E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLE SHOWED NO DAMAGE OR DEFECTS AND PASSED ALL TESTING; THEREFORE, THE REPORTED INCIDENT COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE ESTABLISHED AS NO DEFECTS WERE OBSERVED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304657, BATCH # 4193533. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT SKU: (DNQSYRINGE 10ML LL BNS) 153239 VENDOR PART NO 304657 PRODUCT LOT NUMBER: 4193533 COMPLAINT DETAILS: "DATE OF INCIDENT 4/11/2025 NO PATIENT HARM INVOLVED. DETAILED DESCRIPTION OF THE CONCERN: 10ML SYRINGE IS LEAKING FROM TIP WHEN 25G NEEDLE IS ATTACHED."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397977 BD SYRINGE 10ML LL BN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193533

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown