BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 21154407 · Received January 14, 2025

    Report

    Report Number
    3002682307-2024-00269
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 20, 2024
    Report Date
    February 18, 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
    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 304000 AND LOT NUMBER 240701. 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, ONE (1) PICTURE SAMPLE AND TWO (2) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, ONE (1) NEEDLE IS OBSERVED WITH THE CORRECT LENGTH AND A WELL-FORMED BEVEL, AND THE OTHER NEEDLE IS SHORTER WITHOUT A CANNULA BEVEL. THROUGH MICROSCOPIC EXAMINATION OF THE SHORTER NEEDLE, IT SEEMS THE NEEDLE HAS BEEN BROKEN. CONSIDERING THE PROVIDED INFORMATION OF ¿THE CANNULAS SHOWED MANUFACTURING FAULTS WHICH COULD BE SEEN AFTER USE¿ WE UNDERSTAND THAT THE CANNULA WAS NOT BROKEN BEFORE USE. THEREFORE, WE CANNOT EXCLUDE THAT THE HANDLING OF THE PRODUCT HAD SOME IMPLICATION IN THIS EVENT. AT THIS TIME, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS ISSUE. WE WOULD LIKE TO INFORM YOU THAT THE CANNULAS USED FOR THE MANUFACTURE OF THIS PRODUCT COMPLY WITH ISO STANDARD ISO 9626 ¿STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES¿. IN ACCORDANCE, ANY ISSUES OF BREAKAGE ARE VERY RARE UNLESS SOME INAPPROPRIATE USES OF THE PRODUCT WERE TO OCCUR, FOR SAMPLE, BENDING OF THE NEEDLE DURING USE. 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 NEEDLE IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE ARE REPORTING 2 INCIDENTS INVOLVING BD MICROLANCE 3 30G X ½¿¿ (0.3X13MM) CANULAS REF 304000. ON 2 OCCASIONS WITH TWO DIFFERENT PATIENTS, DURING INJECTIONS OF PRODUCTS, THE CANULAS SHOWED MANUFACTURING FAULTS WHICH COULD BE SEEN AFTER USE: THEY WERE SHORTER AND SLIGHTLY TWISTED WITH A TIP WITHOUT THE CORRECT BEVEL. PHOTOS OF A NORMAL AND A FAULTY CANULA ARE ATTACHED. THE PRODUCTS, BEING OF VERY SMALL VOLUME, COULD NOT BE INJECTED AND WERE LOST. THESE ARE LUCENTIS WITH A PRE-FILLED SYRINGE ON WHICH A BD CANULA IS POSITIONED, WITH THE AIR IN THE CANULA PURGED. ON THE FIRST OCCASION, THE PRACTITIONER DID NOT KEEP THE CANULA. THE SECOND TIME THE CANULA WAS KEPT AND IS AVAILABLE FOR EXPERT EXAMINATION. THIS WAS BATCH 240701, EXPIRY DATE 2029-06. THE UNITS IN THIS BATCH HAVE ALL BEEN QUARANTINED PENDING YOUR INSTRUCTIONS. ANOTHER BATCH ALREADY IN STOCK HAS BEEN SUPPLIED TO USERS. WE LOOK FORWARD TO HEARING FROM YOU REGARDING THE FOLLOW-UP TO THIS MATERIOVIGILANCE ISSUE, AND WILL BE HAPPY TO PROVIDE ANY FURTHER INFORMATION YOU MAY REQUIRE. ADDITIONAL INFORMATION RECEIVED ON 27-DEC-2024: COULD YOU PROVIDE US WITH THE DATES OF THE EVENTS ON THE TWO OCCASIONS THAT OCCURRED? THE DATE OF THE FIRST EVENT IS NOT KNOWN. THE SECOND EVENT OCCURRED ON 20/12/2024. PLEASE CONFIRM IF 2 PATIENTS OR USERS WERE HARMED ON 2 OCCASIONS? IF YES, PLEASE EXPLAIN PATIENTS WERE NOT HARMED: NO INJECTIONS PERFORMED. WE ARE AWARE THAT SAMPLES ARE AVAILABLE FOR INVESTIGATION. COULD YOU PLEASE SPECIFY IF THESE SAMPLES ARE UNUSED (BEFORE USE). USED (DURING OR AFTER USE) THE FAULTY CANULA FROM THE SECOND EVENT IS AVAILABLE FOR INVESTIGATION. IT WAS PUT ON THE SYRINGE PRE-FILLED WITH PRODUCT AND PURGED AFTERWARDS, BUT NO INJECTION WAS MADE. IMPORTANT: IF USED, PLEASE CONFIRM WHETHER THE SAMPLES ARE CONTAMINATED WITH BLOOD OR CYTOTOXIC DRUGS. NO USE IN THE PATIENT, THEREFORE NO CONTAMINATION WITH BLOOD OR CYTOTOXIC PRODUCTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987438 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240701 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown