BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 13689633 · Received March 8, 2022

    Report

    Report Number
    3002682307-2022-00084
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210336. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A VIDEO SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE VIDEO SHOWED THAT THE LIQUID WITHIN THE SYRINGE WILL NOT PASS THROUGH THE NEEDLE, CONFIRMING THAT THE NEEDLE IS CLOGGED. TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR FURTHER EVALUATION. THE RETAINED SAMPLES DID NOT REVEAL ANY SIGNS OF CLOGGING UPON EXAMINATION. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BD MICROLANCE¿ 3 NEEDLES HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID DOES NOT PASS THROUGH THE NEEDLE WHEN IT IS ATTACHED TO THE SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD MICROLANCE¿ 3 NEEDLES HAD BLOCKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID DOES NOT PASS THROUGH THE NEEDLE WHEN IT IS ATTACHED TO THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670949 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown