BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20668246 · Received November 12, 2024

    Report

    Report Number
    3002682307-2024-00239
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 25, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240512. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, 483 SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. 480 OF THE NEEDLES WERE UNUSED AND INSIDE THE BLISTER PACKAGING AND 3 OF THE NEEDLES WERE WITHIN OPENED BLISTER PACKAGES. THE 3 OPENED SAMPLES AND 20 RANDOMLY SELECTED NEEDLES OF THE UNOPENED SAMPLES WERE MICROSCOPICALLY EXAMINED. ALL OF THE CANNULAS SHOWED WELL FORMED BEVELS WITH NO SIGNS OF BLUNT POINT OR DAMAGE. WE WOULD LIKE TO INFORM YOU THAT CANNULA POINT CONDITION IS ROUTINELY TESTED THROUGHOUT THE PRODUCTION PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. WE WOULD ALSO LIKE TO INFORM YOU THAT INTRAOCULAR USE IS NOT VALIDATED BY BD. PLEASE CONTACT YOUR LOCAL BD SALES AND/OR MARKETING ORGANIZATION FOR ADDITIONAL ASSISTANCE. 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.

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME EXCEEDS CHARACTER LIMIT: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES: NEEDLE DEFECT VS. BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: INTRAVITREAL INJECTION WITH 30G CANULA NEEDLE BROKEN AND + SHORT - NOT BEVELED RISK OF INJURY TO THE PATIENT'S EYE AS IT IS NOT BEVELED (NO PATIENT CONSEQUENCES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135245 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240512 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown