BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 HYPODERMIC NEEDLE

    MDR report key: 16565920 · Received March 17, 2023

    Report

    Report Number
    3002682307-2023-00065
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 29, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 302809 AND LOT NUMBER 191020. 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 MICROLANCE NEEDLE SAMPLES BELONGING TO THE REPORTED LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION ALONG WITH TWENTY BD SYRINGES OF MATERIAL 303172. THE RETAINED NEEDLE AND SYRINGE SAMPLES WERE ASSEMBLED BY POSITIONING THE NEEDLE HUBS ON THE SYRINGE TIPS WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE SAMPLES DISPLAYED ANY SIGNS OF DEFECT; THE NEEDLE HUBS FIT PERFECTLY ONTO THE SYRINGE TIPS WITH NO SIGNS OF LEAKAGE. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE CAUSE RELATED TO THE NEEDLE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    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 LEAKAGE OCCURRED BETWEEN THE BD MICROLANCE¿ 3 HYPODERMIC NEEDLE AND SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "[PRODUCT] SPILLS BETWEEN NEEDLE AND SYRINGE''.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD MICROLANCE¿ 3 HYPODERMIC NEEDLE AND SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "[PRODUCT] SPILLS BETWEEN NEEDLE AND SYRINGE''.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742271 BD MICROLANCE¿ 3 HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 191020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown