BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 21433536 · Received February 21, 2025

    Report

    Report Number
    1911916-2025-00135
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 11, 2025
    Report Date
    March 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE PRODUCT BREAKS DURING OPERATION. TO AID IN THE INVESTIGATION, TWO HUNDRED TWENTY-FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS OR DAMAGES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 4081101. 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. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 305127. BATCH#: 4081101. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. BREAKS DURING OPERATION. ADDITIONAL INFO: THANK YOU FOR YOUR REPLY. UNFORTUNATELY, I DO NOT HAVE ANY ADDITIONAL INFORMATION AVAILABLE TO ME TO PROVIDE REGARDING THESE RETURN REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472706 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4081101 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown