BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16892531 · Received May 8, 2023

    Report

    Report Number
    1710034-2023-00494
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 12, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-APR-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE SEALED AND ONE UNSEALED 24GA X 0.56IN. NEXIVA UNIT FROM LOT NUMBER 2182098. THE SEALED UNIT WAS TESTED USING A PENETRATION AND DRAG TEST AND THE UNIT MET THE REQUIRED SPECIFICATIONS. MICROSCOPIC ANALYSIS DISCOVERED THAT THE UNSEALED UNIT HAD A DAMAGED CATHETER TIP. THE REPORTED ISSUE WAS CONFIRMED. ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. DURING MANUFACTURING, WHEN THE CATHETER IS BEING CUT TO LENGTH, DULL BLADES OR WORN TOOLING MAY CAUSE BAD CATHETER TIP QUALITY. SINCE THE DEVICE WITH THE CATHETER TIP DAMAGE WAS UNSEALED, IT IS POSSIBLE THIS ALSO MAY HAVE OCCURRED IN THE CLINICIAN ENVIRONMENT. 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

    H.3. 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 THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TIP SPLIT APART WHILE CANNULATING THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC CANNULA CATHETER TIP SPLINTERED WHEN CANNULATING PATIENT. SKIN WAS PUNCTURED BY CANNULA NEEDLE BUT THE PLASTIC CATHETER COULD NOT BE INSERTED DUE TO DAMAGED TIP AND RESISTANCE. DAMAGED WAS ALSO NOTED ON A DIFFERENT CANNULA LATER IN THE DAY WITH A DIFFERENT PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TIP SPLIT APART WHILE CANNULATING THE PATIENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC CANNULA CATHETER TIP SPLINTERED WHEN CANNULATING PATIENT. SKIN WAS PUNCTURED BY CANNULA NEEDLE BUT THE PLASTIC CATHETER COULD NOT BE INSERTED DUE TO DAMAGED TIP AND RESISTANCE. DAMAGED WAS ALSO NOTED ON A DIFFERENT CANNULA LATER IN THE DAY WITH A DIFFERENT PATIENT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725486 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2182098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown