BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 15507872 · Received September 29, 2022

    Report

    Report Number
    3002682307-2022-00255
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBERS 210335 AND 210338. 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, TWENTY RETAINED SAMPLES OF THE REPORTED LOT WERE OBTAINED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A SYRINGE BY POSITIONING THE HUB ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED SAMPLES DISPLAYED ANY SIGNS OF DEFECT AND THE NEEDLES FIT PERFECTLY ONTO THE SYRINGES WITH NO SIGNS OF LEAKAGE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE NEEDLE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. IT IS POSSIBLE THAT THE REPORTED DEFECT RESULTED FROM DEFECTIVE LUER DIMENSIONS OR DAMAGE TO THE SYRINGE TIP, BUT IT IS ALSO POSSIBLE THAT AN INSUFFICIENT ADJUSTMENT BETWEEN THE DEVICES WAS MADE DURING HANDLING.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 210335, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026, DEVICE MANUFACTURE DATE: 18-MAR-2021. MEDICAL DEVICE LOT #: 210338, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026, DEVICE MANUFACTURE DATE: 25-MAR-2021. 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 2 BD MICROLANCE¿ 3 NEEDLES FROM LOT 210335, AND 1 NEEDLE FROM LOT 210338 LEAKED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WHEN HE ATTACHES THE FINE NEEDLE AND GOES TO INJECT IT, SOME OF THE SOLUTION LEAKS OUT AND HE IS NOT ABLE TO ADMINISTER THE FULL DOSE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICROLANCE¿ 3 NEEDLES FROM LOT 210335, AND 1 NEEDLE FROM LOT 210338 LEAKED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WHEN HE ATTACHES THE FINE NEEDLE AND GOES TO INJECT IT, SOME OF THE SOLUTION LEAKS OUT AND HE IS NOT ABLE TO ADMINISTER THE FULL DOSE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747123 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H10 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown