BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20510607 · Received October 22, 2024

    Report

    Report Number
    1710034-2024-01187
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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 BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383517 AND LOT NUMBER 4030905. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE: I CHECKED THE IV PRIOR TO INSERTIONS AND DID NOT SEE ANY CONCERNS BEFORE ATTEMPTING TO PROCEED. HOWEVER, THE IV DID NOT MAKE IT A THIRD OF THE WAY IN THE VEIN (LOCATED AT THE LEFT ARM ANTECUBITAL VEIN) BEFORE THE CATHETER BENT AND BLOOD START TO POUR OUT OF THE SIDE OF THE CATHETER. I IMMEDIATELY REMOVED AND DRESS THE SITE WITH GAUZE. NO HARM TO THE PATIENT. 9 OCTOBER. THERE WAS NO HARM TO THE PATIENT. THE IV WAS REMOVED AND THROWN AWAY AND A NEW IV WAS STARTED (UNSURE OF LOT NUMBER). ON THE (B)(6) 2024 AT APPROXIMATELY 1300 HOURS, WHILE CONDUCTING AN INTRAVENOUS CATHETER INSERTION FOR PATIENT, ED TECH, HAD THE CATHETER MALFUNCTION DURING THE PROCEDURE. ED TECH CHECKED THE IV PRIOR TO INSERTIONS AND DID NOT SEE ANY CONCERNS BEFORE ATTEMPTING TO PROCEED. HOWEVER, THE IV DID NOT MAKE IT A THIRD OF THE WAY IN THE VEIN (LOCATED AT THE LEFT ARM ANTECUBITAL VEIN) BEFORE THE CATHETER BENT AND BLOOD START TO POUR OUT OF THE SIDE OF THE CATHETER. ED TECH IMMEDIATELY REMOVED AND DRESS THE SITE WITH GAUZE. THE PATIENT DID NOT COMPLAIN OF PAIN OR DISCOMFORT. THE IV USED WAS 20 GUAGE BD NEXIVA CLOSED IV CATHETER SYSTEM-SINGLE PORT WITH LOT NUMBER 4030905 AND REFERENCE CODE (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31438 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030905 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown