BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20624552 · Received November 6, 2024

    Report

    Report Number
    3002682307-2024-00237
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 18, 2024
    Report Date
    January 14, 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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 231106. 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, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A NEEDLE WAS OBSERVED WITH EPOXY (THE ADHESIVE USED) ON THE OUTSIDE PART OF THE HUB, BUT NOT ON THE INSIDE PART WHERE THE HUB AND THE CANNULA SHOULD BE FIXED. TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE INSPECTED AND THEY ALL HAD THE CANNULAS WELL ATTACHED INTO THE HUBS WITH NO INCORRECT EPOXY DOSES OBSERVED. WE CAN CONCLUDE THAT THE ISSUE EXPERIENCED BY THE CUSTOMER RESULTED FROM AN INCORRECT QUANTITY AND LOCATION OF THE ADHESIVE ON THE PRODUCT. THIS MOST LIKELY RESULTED FROM AN INSUFFICIENT DOSAGE OF EPOXY WHICH COULD OCCUR FROM A VISCOSITY VARIATION IN THE EPOXY OR A TEMPORARY STOPPAGE OF THE CANNULA ASSEMBLY STATION. THIS IS A VERY UNUSUAL CIRCUMSTANCE AS ALL OF THE NEEDLES MANUFACTURED ARE INSPECTED FOR THE PRESENCE OF EPOXY AND ANY DEFECTIVE NEEDLES ARE REJECTED. THE CAMERA INSPECTION SYSTEM IS CHALLENGED EVERY EIGHT (8) WORKING HOURS AT THE START OF EACH SHIFT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW 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

    E. ADDRESS EXCEEDS CHARACTER LIMIT: (B)(6). 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 DISCONNECTS FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNULA SECTION TO DISCONNECT FROM THE DEVICE HUB DURING A PROCEDURE THE ABOVE WAS OBSERVED, WHICH CAUSED THE CANNULA SECTION TO DISCONNECT FROM THE DEVICE HUB. DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395659 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 231106 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown