BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22586026 · Received July 24, 2025

    Report

    Report Number
    1911916-2025-00537
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A FILTER NEEDLE WAS REPORTED TO HAVE BROKEN OFF INTO A VIAL. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE SUBMITTED AND REVIEWED BY THE QUALITY TEAM. THE IMAGES DEPICT A SYRINGE WITH THE LOWER PORTION OF THE NEEDLE HUB VISIBLE. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE PHOTOGRAPHS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 305211, LOT 4031348. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF THE PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DESCRIPTION: ¿DURING THE PREPARATION PROCESS, THE FILTER NEEDLE BROKE OFF INTO THE VIAL¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605168 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4031348 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown