BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20456609 · Received October 15, 2024

    Report

    Report Number
    3002682307-2024-00211
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 15, 2024
    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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    DUE TO THE INVESTIGATION FINDINGS, THIS MDR CAN BE CANCELLED. DEFECT ORIGINALLY CODED AS FOREIGN MATTER WITH DT PERFORMED FOR NEEDLE/CLOGGED BLOCKED - HOWEVER, INVESTIGATION RESULTS HAVE DETERMINED THE DIFFICULTY IN USE WAS RELATED TO INSUFFICIENT SILICONE APPLICATION ON THE CANNULA COMPONENT - AS ANALYZED CODE HAS BEEN UPDATED TO NEEDLE PENETRATION DIFFICULT/PAINFUL. THIS IS NOT A MDR REPORTABLE EVENT. INVESTIGATION A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 240203. 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, FIVE (5) NEEDLE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE EXAMINED AND DIPPED INTO A POWDER. THIS IS A TEST THAT ALLOWS US TO ACCESS THE QUANTITY OF SILICONE ON THE CANNULA COMPONENT. AFTER THIS EXAMINATION, THREE (3) OF THE NEEDLES WERE FOUND TO HAVE AN INSUFFICIENT AMOUNT OF SILICONE. BASED ON THE PROVIDED FEEDBACK AND THE SAMPLE RESULTS, WE BELIEVE THIS ISSUE WAS RELATED TO A LACK OF SILICONE ON THE CANNULA. THIS ISSUE MAY OCCUR IF THERE IS A MALFUNCTION IN THE SILICONE DOSAGE DURING THE MANUFACTURING PROCESS. VISUAL INSPECTIONS ARE PERFORMED REGULARLY TO ASSURE THAT THE SILICONE DOSAGE IS CORRECT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. THE MANUFACTURING FACILITY HAS BEEN ALERTED OF YOUR EXPERIENCE TO RAISE ADDITIONAL AWARENESS ON THE PRODUCTION FLOOR FOR THIS POTENTIAL DEFECT AND OPERATOR TRAINING HAS BEEN PERFORMED. ON THE OTHER HAND, WITH THE PROVIDED FEEDBACK, WE MUST NOTE THAT INTRAOCULAR USE IS NOT VALIDATED BY BD FOR THIS PRODUCT. PLEASE CONTACT YOUR LOCAL BD SALES AND MARKETING ORGANIZATION FOR ADDITIONAL ASSISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES A FILM ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE'VE BEEN USING YOUR 30 G CANULAS, REFERENCE 30400, FOR INTRAVITREAL INJECTIONS (IVT) FOR MANY YEARS. OVER THE PAST FEW SESSIONS, THE PRACTITIONER HAS ENCOUNTERED A NEW DIFFICULTY IN FULLY INSERTING THE CANULA. THERE IS A BLOCKAGE IN THE LAST FEW MM, LINKED TO A SMALL FILM. THE PRACTITIONER HAS NOTED THIS PROBLEM WITH CANULAS BELONGING TO LOT 240203. HAS THERE BEEN ANY IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE IN TREATMENT REQUIRED)? NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568801 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240203 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown