BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 21133881 · Received January 12, 2025

    Report

    Report Number
    3002682307-2024-00265
    Event Type
    Malfunction
    Date Received
    January 12, 2025
    Date of Event
    December 19, 2024
    Report Date
    March 6, 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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBERS 240707 AND 240101. 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. ALTHOUGH A SAMPLE SHIPMENT WAS SENT BY THE CUSTOMER, UNFORTUNATELY, THE SHIPMENT WAS LOST BY THE CARRIER. WE APOLOGIZE FOR ANY INCONVENIENCE THIS HAS CAUSED. AS THE SAMPLES WERE UNAVAILABLE, TWENTY (20) RETAINED SAMPLES FROM EACH REPORTED LOT (240707 AND 240101) WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE RETAINED SAMPLES WERE VISUALLY EXAMINED AND NO FOREIGN MATTER WAS OBSERVED. BASED ON THE SAMPLE PRODUCTION HISTORY RESULTS AND THE RETAINED SAMPLE REVIEW, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED AT THIS TIME. IF THE SAMPLES ARE DISCOVERED AND BECOME AVAILABLE, A THOROUGH INVESTIGATION WILL BE COMPLETED. 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 THAT BD CONVENTIONAL NEEDLES EPOXY WAS FOUND ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I WOULD LIKE TO INFORM YOU THAT I HAVE SENT A 2ND MATERIAL SAFETY REPORT TO THE ANSM CONCERNING THE DM AIGUILLE BD MICROLANCE 3 18G 40MM REF (B)(4). PRESENCE OF WHITE MARKS ON THE BODY OF THE CANULA. (B)(6) 2025 CUSTOMER RESPONSE CAN YOU CONFIRM WHEN THE SPILL OCCURRED? DURING USE ON A PATIENT OR BEFORE USE ON A PATIENT? I DON'T THINK IT'S A SPILL, BUT THE PRESENCE OF A WHITE SUBSTANCE - PROBABLY THE ONE USED TO SADDLE THE CANULA IN THE PINK PLASTIC BODY - OBSERVED BEFORE USE. - HAS THE PATIENT OR USER SUFFERED ANY HARM? IF YES, PLEASE EXPLAIN: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460710 BD CONVENTIONAL NEEDLES PERIPHERAL IV CATHETERS FMI BECTON DICKINSON, S.A. 240707 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown