BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23381269 · Received October 24, 2025

    Report

    Report Number
    1911916-2025-00695
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    NA
    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

    IT WAS REPORTED THE PLASTIC HUB BROKE. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, FIVE PHOTOGRAPHS WERE SUBMITTED FOR REVIEW BY THE QUALITY TEAM. ONE IMAGE DEPICTS A SYRINGE WITH THE NEEDLE HUB ASSEMBLED TO THE LUER LOCK AND THE NEEDLE INSERTED INTO A VIAL STOPPER. TWO IMAGES SHOW DAMAGE TO THE UPPER PORTION OF THE NEEDLE HUB, WHILE THE REMAINING TWO DISPLAY A NEEDLE WITH EPOXY BUT WITHOUT THE HUB. 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 REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION 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 SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF A PHYSICAL SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE. 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

    IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE HOLE HAD A HOLE / WAS CRACKED / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 305211 BATCH #: 4031348 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 03SEP2025 XXXX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI ¿ BROKEN FILTER NEEDLE. ON (B)(6) 2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿THE TECH PUT THE NEEDLE ON THE SYRINGE TO DRAW THE MEDICATION OUT OF THE VIAL. WHEN THEY TRIED TO TAKE IT OUT, THE NEEDLE BROKE. THE PLASTIC HUB BROKE AND THE NEEDLE IS STILL STICKING OUT OF THE VIAL.¿ CUSTOMER RESPONSE ON 15-OCT-2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 03SEP2025 2. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028763 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4031348 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown