BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLE

    MDR report key: 17857201 · Received October 2, 2023

    Report

    Report Number
    3002682307-2023-00298
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 18, 2023
    Report Date
    December 18, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1069913. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. H.4. DEVICE MANUFACTURE DATE: 10-MAR-2021. D.4. MEDICAL DEVICE LOT #: 2041117. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. H.4. DEVICE MANUFACTURE DATE: 10-FEB-2022. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304627 AND LOT NUMBERS 1069913 AND 2041117. 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, BOTH PICTURE AND PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, WHITE FOREIGN MATTER WAS OBSERVED ON THE NEEDLE AND IT WAS IDENTIFIED AS EPOXY, WHICH IS THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS. THE CANNULA POINT WAS ALSO OBSERVED DAMAGED. THE EPOXY ON THE CANNULA MOST LIKELY RESULTED FROM A TEMPORARY MALFUNCTION IN THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, A HIGHER QUANTITY OF EPOXY WAS ADDED AND FELL ONTO THE AFFECTED CANNULA. IN REGARDS TO CANNULA POINT CONDITION, THE CANNULA CARTRIDGES ARE DIRECTLY INTRODUCED INTO THE ASSEMBLY MACHINE. A CAMERA SYSTEM INSPECTS ALL NEEDLE POINTS AND REJECTS ANY DEFECTS IDENTIFIED. BASED ON 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE 3 NEEDLE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE SPOTS FOUND ON NEEDLE BEFORE USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846320 BD MICROLANCE 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2041117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown