BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23541959 · Received November 13, 2025

    Report

    Report Number
    1911916-2025-00738
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 9, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. VISIBLE PARTICLE ADHESIONS WERE REPORTED ON NEEDLE FILTERS. TO SUPPORT THE INVESTIGATION, TWENTY-FOUR SAMPLES IN SEALED BLISTER PACKAGING AND THREE PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE RETURNED SAMPLES REVEALED NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATTER. THE PHOTOGRAPHS PROVIDED DEPICTED A NEEDLE PLASTIC SHIELD WITH A DARK-COLORED SPECK, A NEEDLE HUB WITH A DARK COLORED SPECK, AND THE TOP WEB OF A PACKAGING BLISTER. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305211, LOT 4212641, WAS COMPLETED. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE DETECTED DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHS, THE REPORTED CONDITION WAS CONFIRMED; HOWEVER, IT WAS NOT OBSERVED IN THE PHYSICAL SAMPLES RETURNED.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT "AS PART OF OUR QUALITY CONTROL, WE HAVE BEEN MADE AWARE THAT VISIBLE PARTICLE ADHESIONS HAVE BEEN DETECTED ON SOME OF YOUR NEEDLE FILTERS ((B)(4), LOT 4212641). THESE ARE BLACK RESIDUES WHOSE MOBILITY HAS NOT YET BEEN CONCLUSIVELY ASSESSED. WE WOULD THEREFORE LIKE TO ASK YOU TO LET US KNOW WHETHER YOU ARE ALREADY AWARE OF THIS PHENOMENON AND WHETHER ANY QUALITY REPORTS OR ASSESSMENTS HAVE ALREADY BEEN MADE. WE ARE PARTICULARLY INTERESTED IN YOUR ASSESSMENT WITH REGARD TO PATIENT SAFETY AND POSSIBLE EFFECTS DURING USE. WE WOULD BE VERY GRATEFUL FOR YOUR FEEDBACK AND ANY FURTHER INFORMATION ON THE AFFECTED LOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985215 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4212641 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown