BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLE 18G

    MDR report key: 16638235 · Received March 29, 2023

    Report

    Report Number
    3002682307-2023-00084
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 8, 2023
    Report Date
    June 5, 2023
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 220519. 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 (20) RETAINED SAMPLES FROM THE LOT REPORTED WERE OBTAINED FOR EVALUATION FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE ASSEMBLED WITH A BD DISCARDIT 2ML SYRINGE AND LIQUID MOVED THROUGH THE CANNULAS NORMALLY WITH NO SIGNS OF CLOGGING OBSERVED. INSPECTIONS FOR OCCLUSION ARE COMPLETED AFTER ASSEMBLY AND PRIOR TO THE RELEASE OF EACH LOT MANUFACTURED. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. AT THIS TIME, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS 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 10 OF THE BD MICROLANCE¿3 NEEDLE 18G WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE NEEDLE IS CLOGGED AND THEREFORE UNUSABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD MICROLANCE¿3 NEEDLE 18G WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE NEEDLE IS CLOGGED AND THEREFORE UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305773 BD MICROLANCE¿3 NEEDLE 18G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown