BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 15467668 · Received September 22, 2022

    Report

    Report Number
    3002682307-2022-00245
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    August 26, 2022
    Report Date
    October 3, 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. INITIAL REPORTER PHONE #: AN ADDITIONAL PHONE # OF (B)(6) WAS PROVIDED BY THE INITIAL REPORTER. 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

    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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED NEEDLE SAMPLES WERE ASSEMBLED WITH A DISCARDIT 2ML SYRINGE. THROUGH EVALUATION, THE LIQUID WAS FOUND TO MOVE THROUGH THE CANNULA NORMALLY WITH NO SIGNS OF NEEDLE CLOGGING OR NEEDLE DETACHMENT; THEREFORE, WE WERE UNABLE TO REPRODUCE OR CONFIRM THE REPORTED DEFECT. PER THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE OF NEEDLE CLOGGING HAD OCCURRED AND THAT THE NEEDLE DETACHED DUE TO THE INCREASED PRESSURE APPLIED TO PUSH THE PLUNGER. BASED ON THE INVESTIGATION RESULTS AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. THE NEEDLES ARE INSPECTED FOR OCCLUSION EVERY THIRTY MINUTES AS PART OF THE IN-PROCESS INSPECTION AFTER ASSEMBLY. IN CERTAIN CIRCUMSTANCES THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA CAUSING THE NEEDLE TO BECOME BLOCKED/OCCLUDED DUE TO CRYSTALLIZATION OR OTHER SOLUBILIZATION EFFECTS. OCCLUSION IS MOST LIKELY TO OCCUR IF A DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. IF THIS ISSUE WERE TO REOCCUR, WE WOULD APPRECIATE THE OPPORTUNITY TO COMPLETE A THOROUGH SAMPLE ANALYSIS. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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¿ 3 NEEDLES EXPERIENCED CLOGGED NEEDLES, NEEDLE AND SYRINGE SEPARATION, AND LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT REPORTED THAT WHEN THE NURSE WANTED TO DO THE INJECTION, THE SUSPENSION DIDN'T GO THROUGH THE NEEDLE, LIKE THE NEEDLE WAS BLOCKED. THE NURSE THEN TRIED TO PUSH THE PLUNGER HARDER, AND THE NEEDLE GOT DETACHED FROM THE SYRINGE AND ALL THE SUSPENSION SPILLED OUT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 120,000 BD MICROLANCE¿ 3 NEEDLES EXPERIENCED CLOGGED NEEDLES, NEEDLE AND SYRINGE SEPARATION, AND LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:THE PATIENT REPORTED THAT WHEN THE NURSE WANTED TO DO THE INJECTION, THE SUSPENSION DIDN'T GO THROUGH THE NEEDLE, LIKE THE NEEDLE WAS BLOCKED. THE NURSE THEN TRIED TO PUSH THE PLUNGER HARDER, AND THE NEEDLE GOT DETACHED FROM THE SYRINGE AND ALL THE SUSPENSION SPILLED OUT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645708 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown