BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 21934332 · Received April 30, 2025

    Report

    Report Number
    1911916-2025-00317
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    January 15, 2025
    Report Date
    October 14, 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

    DEVICE EVALUATION. IT WAS REPORTED A GREEN PARTICLE WAS OBSERVED IN THE PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO PHOTOS SHOW A NEEDLE ASSEMBLY WITH A GREEN COLORED PARTICLE IN THE NEEDLE HUB. THE OTHER PHOTOS SHOW AN FTIR CHART; THE CHART DOES NOT PROVIDE DETAILS OF THE % MATCHING OF THE PARTICLE THAT WAS TESTED. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, POSSIBLE LOT NUMBERS 4031348, 2299450 AND 3158854. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP: IT WAS REPORTED A GREEN PARTICLE WAS OBSERVED IN THE PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. TO AID IN THE INVESTIGATION, THREE PHOTOS, A MOUNTED GREEN PARTICLE (PROVIDED SEPARATELY) AND AN FTIR REPORT WERE RECEIVED FOR EVALUATION OUR QUALITY TEAM. TWO PHOTOS SHOW A NEEDLE ASSEMBLY WITH A GREEN COLORED PARTICLE IN THE NEEDLE HUB. THE OTHER PHOTOS SHOW AN FTIR CHART; THE CHART DOES NOT PROVIDE DETAILS OF THE % MATCHING OF THE PARTICLE THAT WAS TESTED. WITHOUT ADDITIONAL INFORMATION REQUIRED FROM THE FTIR, BD CANNOT CONFIRM IF ANY SIMILAR MATERIALS USED IN PRODUCTION WOULD PROVIDE SIMILAR RESULTS. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, POSSIBLE LOT NUMBERS 4031348, 2299450 AND 3158854. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL #305211, BATCH # 4031348. IT WAS REPORTED BY THE CUSTOMER THAT THE ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON 15JAN2025*****WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM- SYRINGE. ON 27JAN2025, ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION FILTER NEEDLE, CATALOG: 305211, LOT:4031348, CUSTOMER RESPONDED ON 21-APR. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 15JAN2025. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A. 3. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE TO SEND TO BD FOR INVESTIGATION? SAMPLE WILL NOT BE FORWARDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184560 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON UNKNOWN 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown