BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 20522150 · Received October 24, 2024

    Report

    Report Number
    1911916-2024-00756
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE HUB. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION, AND THEN WITH 30X MAGNIFICATION. THE SAMPLE IS THE NEEDLE HUB WITH NO PLASTIC SHIELD. THE BOTTOM PART OF THE NEEDLE IS IN THE NEEDLE HUB, AND THERE IS ABOUT 1/64" OF THE NEEDLE VISIBLE FROM THE EPOXY. THE NEEDLE IS BENT WITH AN ANGLE OF ABOUT THIRTY DEGREES. THIS DEFECT COULD OCCUR IF THE NEEDLE BECAME BENT AND THEN BROKE DURING USE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 3299707. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305127, BATCH # 3299707. IT WAS REPORTED BY CUSTOMER THAT PRECISION GLIDE NEEDLE BROKE OFF IN PT AT THE HUB, X-RAY AND SCHEDULED SURGERY FOR REMOVAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714220 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3299707 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention