BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 22132263 · Received June 3, 2025

    Report

    Report Number
    1911916-2025-00390
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 27, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    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

    THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. INVESTIGATION RESULTS: A REPORT WAS RECEIVED INDICATING THAT A NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE FILTER NEEDLE CAP. TO SUPPORT THE INVESTIGATION, A PHOTOGRAPH WAS SUBMITTED FOR EVALUATION BY OUR QUALITY TEAM. THE IMAGE DEPICTS A NEEDLE ASSEMBLY WITHIN AN OPENED BLISTER PACKAGE, WITH THE UPPER PORTION OF THE NEEDLE EXTENDING THROUGH THE PLASTIC SHIELD. THIS CONDITION OCCURS IF THE FIXTURE HOLDING THE NEEDLE ASSEMBLY WAS MISALIGNED DURING THE SHIELD ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR MATERIAL NUMBER 305211, LOT 4031348. THE REVIEW FOUND NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE SHIELDING PROCESS CONFIRMED THAT FIXTURE SETTINGS AND ALIGNMENT WERE CORRECT, AND PRODUCT FLOW WAS WITHIN ACCEPTABLE PARAMETERS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SUBMITTED PHOTOGRAPH, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED. 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.

    Description of Event or Problem · 0

    MATERIAL # 305211. BATCH # 4031348. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE FILTER NEEDLE CAP AND THE MEMBER WAS STUCK WITH THE FILTER NEEDLE DRAWING BLOOD UPON OPENING THE PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025 WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ TORN FILTER NEEDLE PACKAGING ON (B)(6) 2025, THE HCP REPORTED, ¿UPON OPENING THE FILTER NEEDLE WRAPPING THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE FILTER NEEDLE CAP. ADDITIONALLY, THE HCP STAFF MEMBER WAS STUCK WITH THE FILTER NEEDLE DRAWING BLOOD UPON OPENING THE PACKAGING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432703 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4031348 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown