BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22354931 · Received June 30, 2025

    Report

    Report Number
    1911916-2025-00468
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    March 20, 2025
    Report Date
    July 7, 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
    117

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING STOPPER CORING. TO SUPPORT THE INVESTIGATION, TWO SAMPLES IN SEALED BLISTER PACKAGING WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE SAMPLES WAS CONDUCTED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE NEEDLE TIP WAS EXAMINED UNDER 30X MAGNIFICATION, REVEALING NO SIGNS OF DAMAGE, DEFECTIVE GRINDING, OR HOOKS. THE BEVELS AND ETCHING WERE FOUND TO BE WITHIN ACCEPTABLE STANDARDS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE IDENTIFIED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING STOPPER CORING. TO SUPPORT THE INVESTIGATION, TWO SAMPLES IN SEALED BLISTER PACKAGING AND THREE PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE SAMPLES WAS CONDUCTED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE NEEDLE TIP WAS EXAMINED UNDER 30X MAGNIFICATION, REVEALING NO SIGNS OF DAMAGE, DEFECTIVE GRINDING, OR HOOKS. THE BEVELS AND ETCHING WERE FOUND TO BE WITHIN ACCEPTABLE STANDARDS. THE SUBMITTED PHOTOGRAPHS DEPICTED THE BOTTOM PORTION OF A NEEDLE ASSEMBLY, A NEEDLE ASSEMBLY INSERTED INTO A STOPPERED VIAL, AND A GRAY PARTICLE. NO ADDITIONAL INFORMATION COULD BE DETERMINED FROM THE IMAGES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE IDENTIFIED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    VERBATIM: THE COMPLAINANTS REPORT PIECES OF STOPPER OBSERVED IN VIALS AFTER THE BD FILTER NEEDLE PIERCE THE STOPPER. MATERIAL: 305211 BATCH#: 4031348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928402 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