BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE

    MDR report key: 18136730 · Received November 14, 2023

    Report

    Report Number
    3002682307-2023-00325
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 20, 2023
    Report Date
    February 27, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 210828 AND 211006. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TEN (10) RETAINED NEEDLE SAMPLES FROM EACH REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE NEEDLES WERE EVALUATED; HOWEVER, NO SIGNS OF DEFECT WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 210828 AND 211006. 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. THREE (3) CAVERJECT KITS WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE CAVERJECT SYRINGES WERE DISASSEMBLED AND ASSEMBLED TO DRAW UP LIQUID. NO ISSUES WERE IDENTIFIED DURING THIS TESTING. THE NEEDLES WERE FOUND TO ASSEMBLE PROPERLY ONTO THE SYRINGES AND NO LEAKAGE OCCURRED. TEN (10) RETAINED NEEDLE SAMPLES FROM EACH REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE NEEDLES WERE EVALUATED; HOWEVER, NO SIGNS OF DEFECT WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. 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 MICROLANCE NEEDLE DETACHED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES ARE DETACHED FROM THE SYRINGE. THE YELLOW PART OF THE SYRINGE BODY CAME OFF. (B)(6)2023. 1. HAS THE PROBLEM BEEN OBSERVED BEFORE USE OR DURING USE ON THE PATIENT? WHEN USED BY THE PATIENT. 2. DID THIS EVENT HAVE ANY NEGATIVE CONSEQUENCES FOR THE PATIENT OR USER? ? LOSS OF THE PRODUCT TO BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913155 BD MICROLANCE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 211006 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown