BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 14861039 · Received June 29, 2022

    Report

    Report Number
    3002682307-2022-00177
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 27, 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. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 200422. 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 OF LOT NUMBER 200422 WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EXAMINED AND NONE OF THE SAMPLES DISPLAYED ANY SIGNS OF CLOGGED OR BLOCKED CANNULA; THEREFORE, WE WERE UNABLE TO REPRODUCE OR CONFIRM THE REPORTED ISSUE AND A DEFINITIVE MANUFACTURING RELATED CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. NEEDLES ARE INSPECTED FOR SIGNS OF OCCLUSION AS PART OF THE IN-PROCESS INSPECTION EVERY THIRTY MINUTES. 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, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 05-JUL-2022 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 200422. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, A SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH TESTING OF THE SAMPLE, THE NEEDLE WAS FOUND CLOGGED, CONFIRMING THE REPORTED DEFECT. THE NEEDLE WAS MICROSCOPICALLY EXAMINED AND CRYSTALLIZED PARTICLES WERE FOUND IN THE CANNULA WHICH WAS POSSIBLY RESIDUE FROM THE MEDICATION USED. TWENTY RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE ALSO OBTAINED FOR EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NONE OF THE NEEDLES SHOWED ANY SIGNS OF CLOGGING. ALTHOUGH THE RETURNED NEEDLE SAMPLE WAS CLOGGED, IT IS NOT POSSIBLE TO IDENTIFY A MANUFACTURING RELATED CAUSE AS THE SAMPLE WAS ALREADY USED; WE DO NOT KNOW IF THE CLOG IS DUE TO CRYSTALLIZATION OF THE MEDICATION USED. NEEDLES ARE INSPECTED FOR SIGNS OF OCCLUSION AS PART OF THE IN-PROCESS INSPECTION EVERY THIRTY MINUTES. 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.

    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: "DECAPEPTYL DEPOT 3.75MG -IL- THE SUSPENSION DIDN'T FLOW THROUGH THE NEEDLE / T17784A, 234670/200422. GREEN CANULA NOT PERMEABLE... THE SYRINGE GOT STUCK AND THE SUSPENSION DIDN'T FLOW THROUGH THE NEEDLE AS IT SHOULD HAVE. THEY COULDN'T PERFORM THE INJECTION."

    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: "DECAPEPTYL DEPOT 3.75MG -IL- THE SUSPENSION DIDN'T FLOW THROUGH THE NEEDLE / T17784A, 234670/200422. GREEN CANULA NOT PERMEABLE. THE SYRINGE GOT STUCK AND THE SUSPENSION DIDN'T FLOW THROUGH THE NEEDLE AS IT SHOULD HAVE. THEY COULDN'T PERFORM THE INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253274 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown