BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN

    MDR report key: 15686685 · Received October 27, 2022

    Report

    Report Number
    1710034-2022-00630
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 28, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE REPORTED LOT, 2080062, COULD NOT BE FOUND IN THE PRODUCTION RECORDS FOR MATERIAL NUMBER 383512.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 2080062 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN THE CATHETER HAD SHEERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPENED A NEW 22G BD CATHETER IN PREPARATION FOR PIV INSERTION. UPON CHECKING CATHETER, NOTICED A CATHETER SHEER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN THE CATHETER HAD SHEERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPENED A NEW 22G BD CATHETER IN PREPARATION FOR PIV INSERTION. UPON CHECKING CATHETER, NOTICED A CATHETER SHEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867915 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown