BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 20761051 · Received November 22, 2024

    Report

    Report Number
    1710034-2024-01386
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 13, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    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: THE COMPLAINT THAT THE CATHETER WOULD NOT SEPARATE FROM THE NEEDLE WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 20GA NEXIVA UNIT FROM LOT: 4193548 WAS PROVIDED FOR INVESTIGATION. RESISTANCE WAS NOTED WHEN ATTEMPTING TO WITHDRAW THE NEEDLE THROUGH THE TIP SHIELD. DEBRIS WAS OBSERVED IN THE WASHER, WHICH LIKELY CAUSED RESISTANCE WHEN ATTEMPTING TO RETRACT THE NEEDLE. THE DAMAGE WAS LIKELY CAUSED DURING MANUFACTURING. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO DIFFICULT TO DISENGAGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN 3 INSTANCES WHERE THE CATHETER WILL NOT SEPARATE FROM THE NEEDLE. ALL 20G, ALL IN THE ER, AND ALL LOT#4193548. ONE CATHETER HAS BEEN SEQUESTERED AT THIS TIME AND THEY ARE GOING TO KEEP ME UPDATED IF THERE ARE ANY MORE ISSUES. (B)(6). 1. WHAT IS THE DATE OF EVENT? 11/1/2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT: PATIENT REQUIRED ADDITIONAL STICK FOR IV PLACEMENT. (B)(6). I HAVE AN UPDATE ON THIS QUESTION AFTER SEEING THE IMPACTED PRODUCT: 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT: NO HARM. UNABLE TO SEPARATE THE CATHETER FROM THE NEEDLE. NEVER USED ON THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758860 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4193548 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown