BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 21283976 · Received January 31, 2025

    Report

    Report Number
    1911916-2025-00071
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. IT WAS REPORTED THE NEEDLE BROKE DURING AN OPERATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305127 AND LOT NUMBER 4081101. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL # 305127 BATCH # 4081101 VERBATIM: THE CUSTOMER ADVISED THAT THE PRECISION NEEDLE BROKE DURING AN OPERATION. 1. WHAT WAS THE IMPACT TO THE PATIENT? SLIGHT DISCOMFORT AND SLIGHT VARIATION IN SCHEDULE TO GET ORDERED XRAY PERFORMED. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. PATIENT HAD SLIGHT DISCOMFORT BUT REPORTED NO PAIN. THE NEEDLE HAS NOW SURFACED AS OF (B)(6) 2025 AND THE PATIENT WAS ABLE TO PULL THE NEEDLE OUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455985 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4081101 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention