BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17276164 · Received July 6, 2023

    Report

    Report Number
    3002682307-2023-00185
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 18-JUL-2023. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300600 AND LOT NUMBER 221209. 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, BOTH PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE CANNULA COMPONENT WAS OBSERVED BROKEN. THROUGH EXAMINATION OF THE SAMPLE, THE EPOXY DOSAGE WAS FOUND TO BE CORRECT. EPOXY IS THE GLUE USED TO JOIN THE CANNULA AND HUB COMPONENTS. THE EPOXY PRESENCE INDICATES THAT THE CANNULA WAS PROPERLY ASSEMBLED INTO THE HUB BEFORE USE. A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT. IT IS POSSIBLE THAT THE HANDLING OF THE PRODUCT HAD AN IMPLICATION IN THIS ISSUE. ANY BREAKAGE ISSUES ARE VERY RARE AND MAY BE CAUSED BY AN INAPPROPRIATE USE OF THE PRODUCT, SUCH AS BENDING OF THE NEEDLE WHILE INJECTING. A CANNULA PULL OUT TEST IS PERFORMED FOR EACH LOT PRODUCED PRIOR TO RELEASE. 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.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MICROLANCE¿ 3 NEEDLE THE NEEDLE BROKE OFF. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: YESTERDAY WE HAD TO DRAW BLOOD FROM A CAT, AND THE NEEDLE BROKE OFF. CAT HAD SURGERY TO REMOVE THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MICROLANCE¿ 3 NEEDLE THE NEEDLE BROKE OFF. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: YESTERDAY WE HAD TO DRAW BLOOD FROM A CAT, AND THE NEEDLE BROKE OFF. CAT HAD SURGERY TO REMOVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498038 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 221209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention