BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16910817 · Received May 11, 2023

    Report

    Report Number
    1710034-2023-00499
    Event Type
    Malfunction
    Date Received
    May 11, 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 : BD RECEIVED ONE SEALED AND ONE OPENED 24GA X 0.56IN. NEXIVA UNIT FROM LOT NUMBER 2182098. THROUGH THE MICROSCOPIC ANALYSIS A DAMAGED CATHETER TIP WAS OBSERVED WITH THE OPEN UNIT. THE REPRESENTATIVE UNIT WAS TESTED USING A PENETRATION AND DRAG TEST WHERE THE UNIT MET THE REQUIRED SPECIFICATIONS. THE REPORTED ISSUE WAS CONFIRMED WITH THE UNIT THAT WAS OPENED. SINCE THE UNIT WAS RECEIVED IN OPENED PACKAGING, BD COULD NOT DETERMINE A DEFINITE ROOT CAUSE. WE WERE UNABLE TO DETERMINE WHETHER THE DAMAGE OBSERVED HAPPENED DURING TIP ADHESION BREAK, REMOVAL OF THE NEEDLE COVER OR DURING MANUFACTURING DUE TO DULL BLADES, WORN TOOLING OR LUBRICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 2ND 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 BUT CATHETER 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 2ND 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 BUT CATHETER 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
    1165483 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2182098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown