BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20GA 1.00IN HF Y

    MDR report key: 19667910 · Received July 3, 2024

    Report

    Report Number
    1710034-2024-00684
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 14, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 383536 AND LOT NUMBER 4030906 . 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 THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. ALTHOUGH AN EXACT CAUSE COULD NOT BE IDENTIFIED FOR THIS INCIDENT, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ANY REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20GA 1.00IN HF Y NEEDLE DISENGAGEMENT IS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿A 20G IV (BD NEXIVA) WAS PLACED IN THE LAC WITH NEW ISSUE. WHILE ATTEMPTING TO REMOVE THE SAFETY NEEDLE, UNABLE TO REMOVE. MECHANISM WAS STUCK TO CATHETER. PIV HAD TO BE REMOVED.¿

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 1. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. 2. WHAT WAS THE IMPACT TO THE PATIENT? THE PATIENT HAD TO BE STUCK TWICE. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473640 BD NEXIVA 20GA 1.00IN HF Y PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown