BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 21283256 · Received January 31, 2025

    Report

    Report Number
    1911916-2025-00067
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 1, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. BATCH: 3209587 BATCH CREATION DATE: 2023-07-28 BATCH EXPIRATION DATE: 2028-09-30 FULL UDI: (B)(4). BATCH: 4081101 BATCH CREATION DATE: 2024-03-21 BATCH EXPIRATION DATE: 2029-06-30 FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE FULL AMOUNT OF THE MEDICATION COULD NOT BE INJECTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305127 AND LOT NUMBERS 3209587 AND 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 # 3209587, 4081101. VERBATIM: THE NEEDLE IS GETTING STUCK SO THE FULL AMOUNT OF MEDICATION CANNOT BE INJECTED OCCURRENCES: 5 EA (BETWEEN TWO BOXES).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510611 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4081101 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown