BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 18027110 · Received October 29, 2023

    Report

    Report Number
    1710034-2023-01237
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 14, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 18GA X 1.25IN. NEXIVA UNIT FROM LOT NUMBER 3180986. A GROSS VISUAL INSPECTION SHOWS THAT THE CATHETER ASSEMBLY HAS BEEN DECOUPLED FROM THE TIP SHIELD. PER THE REPORT, DISCOMFORT WAS FELT WHEN PLACING THE UNIT. MICROSCOPIC ANALYSIS DISCOVERED THERE WAS A V SHAPE CUT TO THE CATHETER TIP, AND SIGNIFICANT DAMAGE AROUND THE BEVEL OF THE CATHETER TIP. THE REPORTED ISSUE WAS CONFIRMED AND DETERMINED TO BE MANUFACTURING RELATED DUE TO AN INCORRECT CUT IN THE CATHETER TUBING. DURING MANUFACTURING, WHEN THE CATHETER IS BEING CUT TO LENGTH, DULL BLADES OR WORN TOOLING MAY CAUSE BAD CATHETER TIP QUALITY. EXPIRED LUBE MAY ALSO CAUSE POOR CATHETER TIP QUALITY. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT CATHETER FRAYED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE RN PLACING THE IV NOTED THE PATIENT'S DISCOMFORT WITH PLACING THE IV, REMOVED THE IV FROM THE PATIENT'S ARM AND SAW THE CATHETER IS DAMAGED. A NEW IV WAS PLACED IN THE OTHER ARM. 16 OCT 23 GOOD MORNING, SEE ANSWERS BELOW. THANKS! -IS THERE ANY OTHER ADVERSE EVENT ON PATIENT OTHER THAN THE REPORTED PREVIOUSLY? THE NEEDLE PUNCTURED THE PATIENT¿S SKIN BUT DUE TO THE FRAYED CATHETER, THE PATIENT EXPERIENCED PAIN AS THE CATHETER COULD NOT BREAK THROUGH THE PATIENT¿S SKIN. -IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? THE PATIENT REQUIRED A SECOND IV PLACEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207748 BD NEXIVA 18 GA X 1-1/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180986 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown