BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 NEEDLE

    MDR report key: 11340699 · Received February 17, 2021

    Report

    Report Number
    3002682307-2021-00057
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 22, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/12/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 190323. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS DEFECT, TWENTY SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE ASSEMBLED WITH AN EMERALD SYRINGE. ALL OF THE SAMPLES FUNCTIONED PER SPECIFICATION WITH NO SIGNS OF CLOGGING IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE IDENTIFIED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE WAS BLOCKED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MANY OF THESE NEEDLES ARE PARTIALLY BLOCKED BY UNIDENTIFIED MATERIAL AND ARE VERY DIFFICULT TO USE FOR INJECTIONS."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD MICROLANCE¿ 3 NEEDLE WAS BLOCKED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MANY OF THESE NEEDLES ARE PARTIALLY BLOCKED BY UNIDENTIFIED MATERIAL AND ARE VERY DIFFICULT TO USE FOR INJECTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236459 BD MICROLANCE 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190323

    Patients

    Seq Age Sex Outcome Treatment
    1