BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE

    MDR report key: 18461372 · Received January 7, 2024

    Report

    Report Number
    3002682307-2023-00367
    Event Type
    Malfunction
    Date Received
    January 7, 2024
    Date of Event
    December 11, 2023
    Report Date
    March 11, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903006007
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300600 AND LOT NUMBER 210312. 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, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUE AND AN EXACT CAUSE COULD NOT BE DETERMINED. PER PROVIDED FEEDBACK, WE UNDERSTAND ISSUE WAS CANNULA WAS SEPARATED FROM HUB. CANNULA IS JOINED INTO THE HUB DUE TO A EPOXY RESIN. ALL NEEDLES ARE 100% INSPECTED FOR PRESENCE OF EPOXY IN THE MANUFACTURING PROCESS, ANY NEEDLE WITH ABSENCE OR IMPROPER AMOUNT OF ADHESIVE IS REJECTED. IN ADDITION, THIS CAMERA SYSTEM IS CHALLENGED EVERY 8 WORKING HOURS AT THE BEGINNING OF EVERY SHIFT. THEREFORE, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CERTAIN THAT THE PROBABILITY OF OCCURRENCE OF THIS INCIDENT IS REALLY LOW, AND IT SHOULD CORRESPOND TO A VERY ISOLATED CASE. 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. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE DISENGAGED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THIS NEEDLE WAS SEPARATED FROM THE SUPPORT, LEAVING THE SUPPORT AND THE SYRINGE ATTACHED BUT THE NEEDLE STUCK IN THE PATIENT'S ARM. IT COULD BE REMOVED WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600591 BD NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 210312 00382903006007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown