BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 15554189 · Received October 6, 2022

    Report

    Report Number
    3002682307-2022-00261
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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

    INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210828. 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. 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 THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID COMES OUT BETWEEN THE SYRINGE AND THE NEEDLE, THEY HAVE CHECKED AND THE NEEDLE IS CORRECTLY ATTACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID COMES OUT BETWEEN THE SYRINGE AND THE NEEDLE, THEY HAVE CHECKED AND THE NEEDLE IS CORRECTLY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417765 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown