BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ SINGLE PORT WITH MAXZERO¿ CLOSED IV CATHETER

    MDR report key: 16502868 · Received March 8, 2023

    Report

    Report Number
    1710034-2023-00203
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    April 4, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903835577
    PMA / PMN Number
    K170336
    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 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FOZ. COMMON DEVICE NAME: INTRAVACULAR CATHETER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INTRODUCING THE BD NEXIVA¿ SINGLE PORT WITH MAXZERO¿ CLOSED IV CATHETER THE NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE WAS ATTEMPTING TO START AND IV, WHEN THREADING THE CATHETER THE WIRE WENT THROUGH THE PLASTIC CATHETER TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INTRODUCING THE BD NEXIVA¿ SINGLE PORT WITH MAXZERO¿ CLOSED IV CATHETER THE NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE WAS ATTEMPTING TO START AND IV, WHEN THREADING THE CATHETER THE WIRE WENT THROUGH THE PLASTIC CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137018 BD NEXIVA¿ SINGLE PORT WITH MAXZERO¿ CLOSED IV CATHETER INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8025512 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown