BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER

    MDR report key: 16510536 · Received March 9, 2023

    Report

    Report Number
    1710034-2023-00208
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    November 19, 2022
    Report Date
    March 23, 2023
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF SAFETY ISSUE WE HAD A PATIENT SAFETY LEARNING SYSTEM (PSLS) EVENT FROM AN BD IV INSERTION SET (B)(4) BREAKING. IT'S UNDER PSLS ID (B)(4). I DO NOT HAVE THE SPECIFIC PACKAGING/LOT NUMBER BUT I DO HAVE THE DATE/TIME IT WAS FOUND. NOV 12/19 BETWEEN 1000-1030.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF SAFETY ISSUE: WE HAD A PATIENT SAFETY LEARNING SYSTEM (PSLS) EVENT FROM AN BD IV INSERTION SET (BD 383557) BREAKING. IT'S UNDER PSLS ID 1361616. I DO NOT HAVE THE SPECIFIC PACKAGING/LOT NUMBER BUT I DO HAVE THE DATE/TIME IT WAS FOUND. NOV 12/19 BETWEEN 1000-1030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629601 BD NEXIVA¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown