BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 17987800 · Received October 23, 2023

    Report

    Report Number
    1710034-2023-01216
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 18GA X 1.25IN NEXIVA UNIT FROM LOT NUMBER 3180986. A CANNULA WAS NOT PRESENT. THROUGH THE VISUAL INSPECTION, THE CATHETER TIP APPEARED SIGNIFICANTLY DAMAGED THEREFORE CONFIRMING THE REPORTED ISSUE. FURTHER MICROSCOPIC ANALYSIS DISCOVERED A V-SHAPE CUT TO THE CATHETER TIP AND DAMAGE AROUND THE BEVEL OF THE CATHETER TIP. THE FORMATION OF THE CUT OBSERVED WAS LIKELY DUE TO THE MANUFACTURING PROCESS. DURING MANUFACTURING WHEN THE CATHETER IS BEING CUT TO LENGTH, DULL BLADES OR WORN TOOLING MAY CAUSE INADEQUATE CATHETER TIP QUALITY. AN INCORRECT CUT OF THE CATHETER TUBING WOULD ALIGN WITH THE NEEDLE PENETRATION BEING DIFFICULT OR PAINFUL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF BATCH 3180986. OPERATORS PERFORM IN PROCESS SAMPLING, SET-UP AND TRAINING THROUGHOUT THE MANUFACTURING PROCESS. PREVENTATIVE MAINTENANCE (PM'S) ARE ALSO PERFORMED PERIODICALLY TO ENSURE PROPER FUNCTION OF THE EQUIPMENT.

    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

    IT WAS REPORTED THAT BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT CATHETER FRAYED DURING INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS ISSUE HAS BEEN SEEN TWICE NOW AT MAYO ¿ THE FIRST TIME, THE CATHETER WASN¿T SAVED FOR SENDING IN ¿ AND IS COMPLETELY DIFFERENT THAN THE ISSUE WE¿RE SEEING WITH THE 20G NEEDLES. BOTH ISSUES ARE PUTTING OUR PATIENTS AT RISK, CAUSING THEM DISCOMFORT, EACH TIME REQUIRING ADDITIONAL IV PLACEMENTS WHICH CAN BE DETRIMENTAL IN OUR HIGH-RISK PATIENTS WHO HAVE LIMITED VEIN ACCESS. NOT TO MENTION THE INCREASING FRUSTRATION WITH THE STAFF USING THESE NEEDLES AND SEEING ¿NOTHING BEING DONE¿ ABOUT THE NUMEROUS REPORTS THAT HAVE BEEN FILED. AS WE¿VE STATED, THESE IVS ARE PLACED BY SEASONED STAFF, INCLUDING OUR IV TEAM WHO ARE HIGHLY TRAINED INDIVIDUALS WHOSE SOLE PURPOSE IS TO PLACE IVS IN OUR PATIENTS FOR THEIR EXAMS. EVENT 2 ((B)(4)): THIS IV WAS PLACED IN A PATIENT'S VEIN CAUSING GREAT DISCOMFORT, THE PATIENT YELLED OUT IN PAIN AND PULLED THEIR ARM AWAY, REMOVING THE IV. THE END OF THE CATHETER ON THIS IV APPEARS TO BE FRAYED WHICH LIKELY CAUSED THIS DISCOMFORT. THE PATIENT REQUIRED A SEND IV PLACEMENT. I HAVE THE CATHETER AT MY DESK FOR RETURNING IF NEEDED. (B)(6) 2023. (B)(4): EVENT 2. -PLEASE ADVISE ON THE OCCURRENCE DATE. THIS WAS REPORTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069962 BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180986 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown