BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17596431 · Received August 22, 2023

    Report

    Report Number
    1710034-2023-00937
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 4, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835189
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLS HAVE GON THROUGH THE CATHETER. REPORT 2 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OVER THE PAST WEEK THERE HAVE BEEN 3 INSTANCES WHERE THE NEEDLES FOR OUR 1.75 INCH PERIPHERAL IVS HAVE CUT THROUGH THE CATHETERS WHILE INSERTING ULTRASOUND GUIDED IVS. WE HAVE A PICTURE OF ONE AND HAVE KEPT A SAMPLE OF ANOTHER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLS HAVE GON THROUGH THE CATHETER. REPORT 2 OF 3. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: OVER THE PAST WEEK THERE HAVE BEEN 3 INSTANCES WHERE THE NEEDLES FOR OUR 1.75 INCH PERIPHERAL IVS HAVE CUT THROUGH THE CATHETERS WHILE INSERTING ULTRASOUND GUIDED IVS. WE HAVE A PICTURE OF ONE AND HAVE KEPT A SAMPLE OF ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52594 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2300204 30382903835189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown