BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 19921147 · Received August 6, 2024

    Report

    Report Number
    3002682307-2024-00158
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 231108. 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. A PULL TEST (A TEST THAT SHOWS THE FORCE NECESSARY TO SEPARATE THE CANNULA FROM THE HUB) IS PERFORMED IN LINE AND BEFORE PRODUCT RELEASE. THE PRODUCTION RECORDS SHOWED THAT THE PULL TEST RESULTS WERE WITHIN SPECIFICATIONS. ALL DAILY COMMENTS FROM THE SHIFT LEADERS WERE ALSO REVIEWED FOR ANY COMMENTS ON THE INVOLVED ASSEMBLY MACHINES, AND NO ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. PREVENTIVE MAINTENANCE RECORDS WERE ALSO CHECKED, AND NO ISSUES WERE FOUND. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR (4) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURES SHOWED A CANNULA SEPARATED FROM THE HUB COMPONENT WITHIN THE PATIENT¿S EYE, THE LOOSE CANNULA HELD BY TWEEZERS, THE SHELF CARTON LABEL CONTENT, AND THE NEEDLE WITHOUT THE CANNULA. THE NEEDLE IMAGE SHOWED A HUB COMPONENT WITH SOME EPOXY OBSERVED. THE PHYSICAL SAMPLE SHOWS THE LOOSE CANNULA COMPONENT AND THE HUB COMPONENT WITH SOME EPOXY ON THE OUTSIDE PORTION BUT NOT ON THE INSIDE OF THE HUB WHERE THE EPOXY AND THE FIXED CANNULA SHOULD BE LOCATED. TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER REVIEW. THE RETAINED SAMPLES WERE EXAMINED AND ALL OF THE CANNULAS DISPLAYED THE CORRECT AMOUNT OF EPOXY AND WERE WELL ATTACHED INTO THE HUB COMPONENTS. WE CAN CONFIRM THAT THIS INCIDENT RESULTED BECAUSE THE PRESENCE OF THE ADHESIVE USED (EPOXY) IN THE NEEDLE WAS NOT IN THE APPROPRIATE QUANTITY NOR THE APPROPRIATE SITE. THIS INSUFFICIENT DOSAGE OF EPOXY CAUSED THE METAL CANNULA TO DISENGAGE FROM THE PLASTIC HUB. THIS COULD HAPPEN DURING THE CANNULA ASSEMBLY PROCESS BECAUSE OF A VISCOSITY VARIATION IN THE EPOXY OR FROM A TEMPORARY STOPPAGE OF THE CANNULA ASSEMBLY STATION. THIS IS CONSIDERED A VERY UNUSUAL CIRCUMSTANCE BECAUSE THE NEEDLES ARE 100% INSPECTED FOR THE PRESENCE OF EPOXY IN THE MANUFACTURING PROCESS WITH ANY DEFECTIVE NEEDLES REJECTED. THE CAMERA SYSTEM IS CHALLENGED EVERY EIGHT (8) WORKING HOURS AT THE BEGINNING OF EACH SHIFT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. THE MANUFACTURING PERSONNEL HAVE BEEN ALERTED OF THIS INCIDENT TO RAISE AWARENESS ON THE PRODUCTION FLOOR AND TRAINING WILL BE PERFORMED WITH THE ASSOCIATES IN RESPONSE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. WE WOULD LIKE TO INFORM YOU THAT INTRAOCULAR USE IS NOT VALIDATED BY BD FOR THIS PRODUCT. PLEASE CONTACT YOUR LOCAL BD SALES AND MARKING ORGANIZATION FOR ADDITIONAL ASSISTANCE.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. 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

    (B)(6) 2024: PATIENT WAS RECEIVING A BILATERAL EYLEA INJECTION TODAY. THE LEFT EYE INJECTION PROCEEDED WITHOUT INCIDENT. AFTER DELIVERING THE DRUG TO THE RIGHT EYE, WHEN REMOVING THE NEEDLE FROM THE EYE THE NEEDLE CAME OUT OF THE NEEDLE HUB AND REMAINED IN THE PATIENTS EYE. THE NEED WAS THEN REMOVED WITH TWEEZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805527 NEEDLE 30GA 1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 231108 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown