BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE

    MDR report key: 18335984 · Received December 15, 2023

    Report

    Report Number
    3002682307-2023-00357
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 23, 2023
    Report Date
    March 6, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903004003
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 300400 AND POTENTIAL LOT NUMBERS 220418 AND 220526. 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) NEEDLE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLE SAMPLE WAS EXAMINED MICROSCOPICALLY AND WAS FOUND TO BE CLOGGED BECAUSE OF SOME CRYSTALLINE PRODUCT THAT COULD BE IDENTIFIED AS GLASS BEADS. IT HAS BEEN DETERMINED THAT THE CLOGGED CANNULA RESULTED FROM THE GLASS BEADS USED DURING THE POLISHING PROCESS OF THE CANNULA BEVELS. DURING THE CANNULA ASSEMBLY PROCESS, NEEDLES ARE INSPECTED THROUGH USE OF A CAMERA SYSTEM. THE CAMERA SENSES A LIGHT SOURCE POSITIONED ON THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION MAY BE PRESENT, AND THE NEEDLE IS AUTOMATICALLY REJECTED. ADDITIONAL INSPECTIONS FOR OCCLUSION ARE ALSO COMPLETED AFTER ASSEMBLY AND PRIOR TO THE RELEASE OF EACH LOT MANUFACTURED. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT 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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE NEEDLE IS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES BD MICROLANCE 3 25G X 1¿ ¿ NR. 18 0.5 X 25MM A CONSULTANT HAS SAID SOME FEEL BLOCKED. A CONSULTANT HAS SAID THAT SOME, NOT ALL, ORANGE NEEDLES FEEL LIKE THEY ARE BLOCKED AND WILL NOT ALLOW FOR ANYTHING TO BE PUSHED DOWN THEM THEREFORE PREVENTING INJECTION. ADDITIONAL INFORMATION: 28 NOV. HELLO - I HAVE CHECKED WITH OUR CONSULTANT WHO RAISED THE ISSUE. THERE HAVE BEEN 4-5 NEEDLES NOTICED WITH THIS DEFECT. - THERE HAS BEEN NO DIRECT PATIENT IMPACT AS THE CONSULTANT STATED THAT THEY ALWAYS FLUSH THE NEEDLE PRIOR TO USING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928323 BD MICROLANCE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. UNKNOWN 00382903004003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown