BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN

    MDR report key: 16075084 · Received December 29, 2022

    Report

    Report Number
    3002682307-2022-00353
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 8, 2022
    Report Date
    December 13, 2022
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 200422. MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. DEVICE MANUFACTURE DATE: 2020-04-29. MEDICAL DEVICE LOT #: 200904. MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. DEVICE MANUFACTURE DATE: 2020-04-29. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND POTENTIAL LOT NUMBERS 200422 AND 200904. 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 FOR EACH POTENTIAL LOT NUMBER REPORTED WERE OBTAINED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE NEEDLE SAMPLES WERE ASSEMBLED WITH A DISCARDIT 2ML SYRINGE AND LIQUID WAS FOUND TO MOVE THROUGH THE CANNULA NORMALLY WITH NO SIGNS OF CLOGGING OR OCCLUSION. BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE OF CLOGGED NEEDLE TOOK PLACE AT THE USER LOCATION. INSPECTIONS FOR OCCLUSION ARE ALSO COMPLETED AFTER ASSEMBLY WITHIN THE MANUFACTURING FACILITY. 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 CANNOT BE DETERMINED FOR THIS REPORTED INCIDENT. IF THIS EVENT WERE TO REOCCUR, WE WOULD APPRECIATE THE OPPORTUNITY TO COMPLETE A THOROUGH ANALYSIS OF THE AFFECTED PRODUCT SAMPLE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 120,000 BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SUSPENSION DIDN'T FLOW THROUGH THE NEEDLE. GREEN CANULA NOT PERMEABLE. PHARMACIST FORWARDED A REPORT FROM THE NURSE, SAYING THE INJECTION WAS STOPPED SO THEY COULDN'T INJECT THE SUSPENSION, THE SUSPENSION DIDN'T GO THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824854 BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown