BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB NS

    MDR report key: 24885358 · Received April 15, 2026

    Report

    Report Number
    1911916-2026-00172
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 29, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903030187
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT A DIRTY NEEDLE WAS FOUND IN THREE PACKS ASSOCIATED WITH THIS LOT NUMBER. TO SUPPORT THE INVESTIGATION, THE QUALITY TEAM RECEIVED FORTY FIVE SAMPLES WITHOUT PACKAGING INFORMATION AND FOUR PHOTOGRAPHS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AT 10X MAGNIFICATION. AN EPOXY DRIP WAS OBSERVED ON THE NEEDLE OF TWENTY THREE SAMPLES. THE FOUR PHOTOGRAPHS PROVIDED DEPICT SOME OF THE SAMPLES RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE NOTED. THIS CONDITION MAY HAVE RESULTED FROM A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303018, LOT 5210526. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS ALSO PERFORMED, THE SETTINGS WERE CORRECT, AND PRODUCT FLOW WAS ACCEPTABLE. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION FINDINGS AND THE RETURNED SAMPLE EVALUATION, THE CUSTOMER REPORTED SYMPTOM IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED, DIRTY NEEDLE FOUND IN THREE PACKS UNDER THIS LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158855 NEEDLE 25X1-1/2 RB NS NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5210526 00382903030187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown