BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19478394 · Received June 6, 2024

    Report

    Report Number
    1710034-2024-00528
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 10, 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
    CA
    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: THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED AND THE CAUSE APPEARED TO BE ASSOCIATED WITH USE. ONE 20G NEXIVA UNIT FROM LOT #3234047 WAS PROVIDED FOR INVESTIGATION. THE CATHETER WAS RECEIVED WITH A V-SHAPED BREACH IN THE TUBING, WHICH WAS CONSISTENT WITH NEEDLE PUNCTURE DAMAGE. WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED THROUGHOUT THE CATHETER TUBING, WHICH INDICATES THAT THE PRODUCT WAS USED. HAD THE DAMAGE EXISTED PRIOR TO INSERTION, THE CATHETER WOULD NOT LIKELY BE PLACED. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE INSTRUCTIONS FOR USE (IFU) STATE, "IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR." A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT PINK 20GX31.75MM NEXIVA NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED A 20G NEXIVA IV. FELT SIGNIFICANT RESISTANCE DURING THE PROCEDURE. PULLED THE IV OUT FOR THIS REASON, UPON DOING SO NOTED THAT SOMEHOW THE SHARP HAD GONE THROUGH THE CANNULA. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055942 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234047 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown