BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 21469372 · Received February 26, 2025

    Report

    Report Number
    3002682307-2025-00028
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    October 29, 2024
    Report Date
    April 2, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    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 303262 AND LOT NUMBER 240305. 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 RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A BD DISCARD IT 2ML SYRINGE BY FOLLOWING THE INSTRUCTIONS AND POSITIONING THE HUB ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NO SIGNS OF DEFECTIVE HUB CONNECTION WERE OBSERVED WITH ANY OF THE RETAINED SAMPLES. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. PER THE PROVIDED FEEDBACK, WE UNDERSTAND A DEFECTIVE CONNECTION TOOK PLACE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD RESULT FROM DEFECTIVE LUER DIMENSIONS, DAMAGE TO THE SYRINGE TIP, OR AN INEFFECTIVE ADJUSTMENT BETWEEN THE DEVICES BY THE END USER. WITH 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.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE/SYRINGE CONNECTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE ARE INFORMING YOU OF A MATERIOVIGILANCE REPORT (INTERNAL SHEET: 1861) DATED (B)(6) 2024 REGARDING THE FOLLOWING MEDICAL DEVICE: INDEED, WHEN USED, IT WAS POSSIBLE TO EXTRACT THE PRODUCT BUT WHEN REINJECTING, THERE WAS SIGNIFICANT RESISTANCE. MISALIGNMENT OF THE SYRINGE TROCAR AND SPLASHING. 3 CANULAS CONCERNED, FROM THE SAME BATCH. (B)(6) 2025: HAS THERE BEEN AN IMPACT ON PATIENTS? NO. COULD YOU CONFIRM? WHAT WAS THE SUBSTANCE SPLASHED? NO INFORMATION TO DATE COULD YOU PROVIDE THE PHOTOS OF THE DEFECTIVE PRODUCT? NO PHOTO AVAILABLE. WAS THERE ANY EXPOSURE OF A HEALTHCARE WORKER TO THE SPLASHED PRODUCT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039267 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240305 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown