BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 22GA 1-1/2IN

    MDR report key: 22196585 · Received June 12, 2025

    Report

    Report Number
    3002682307-2025-00080
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    February 9, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903010004
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301000 AND LOT NUMBER 220921. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES OF REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE NEEDLES WERE ASSEMBLED WITH A BD DISCARDIT SYRINGE; HOWEVER, NO SIGNS OF DEFECTIVE CONNECTION OR LEAKAGE WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHICH CAUSED A LEAKAGE ISSUE DURING THE PRODUCTION OF ONE OF OUR PRODUCTS. EVENT DETAILS: MATERIAL: 301000, BATCH#: 220921. I¿M SENDING THIS EMAIL TO RAISE A COMPLAINT REGARDING A DEFECTIVE MICROLANCE NEEDLE ITEM, CODE: 301000, BATCH: 220921, WHICH CAUSED A LEAKAGE ISSUE DURING THE PRODUCTION OF ONE OF OUR PRODUCTS. THE LEAKAGE OCCURRED FROM THE HIGHLIGHTED AREA IN THE SCHEME BELOW, AT THE WELDING POINT BETWEEN THE METAL NEEDLE AND THE PLASTIC HOUSING ATTACHED TO THE FILTER: ADDITIONAL INFORMATION RECEIVED ON 27/MAY/2025: 1. KINDLY PROVIDE THE DATE OF EVENT. THIS EVENT OCCURRED WITH THE SAME BATCH: 220921 IN TWO SEPARATE OCCASIONS, ON 19 JULY 2024 AND ON 09 FEBRUARY 2025. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? DUE TO OUR PRODUCTION PROCESS, WHICH INVOLVES THE PRESENCE OF RADIOACTIVE MATERIAL, FOR RADIOPROTECTION REASONS, WE DO NOT RECOVER THE MATERIALS USED AND THEY ARE DISPOSED OF AT THE END OF PRODUCTION. THEREFORE, WE ARE UNABLE TO PROVIDE YOU THE DEFECTIVE NEEDLE OR TAKING ANY PICTURE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. FOR THE EVENTS REPORTED IN THE TWO DEVIATIONS RAISED FROM OUR SIDE, THE IMPACT ON PRODUCT QUALITY AND SAFETY WAS EXCLUDED DURING THE IMPACT ASSESSMENT PHASE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078371 NEEDLE 22GA 1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 220921 00382903010004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown