BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17080917 · Received June 7, 2023

    Report

    Report Number
    1710034-2023-00634
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 13, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    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

    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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN THERE WAS A HOLE IN THE CATHETER AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE 22 GA NEXIVA, REF (B)(4), LOT# 2182272. THE CATHETER/NEEDLE WERE DISCARDED SO WE DON¿T HAVE PRODUCT TO RETURN, UNFORTUNATELY. 22G NEXIVA CATHETER USED TO START PIV IN RIGHT FOREARM. CATHETER WAS MOSTLY ADVANCED WHEN NEEDLE WAS REMOVED. NOTED BLEEDING FROM SITE. GENTLE PRESSURE HELD AT SITE FOR A FEW SECONDS AND BLEEDING STOPPED. CATHETER FLUSHED WITH NS AND NOTED LEAKING AT SITE. CATHETER PULLED BACK A LITTLE AND NOTED SMALL HOLE IN CATHETER. CATHETER REMOVED AND PIV STARTED IN NEW VEIN. CATHETER WAS BD NEXIVA 22G X1" LOT NUMBER 2182272 REF (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN THERE WAS A HOLE IN THE CATHETER AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE SEE 22 GA NEXIVA, REF 383512, LOT# 2182272. THE CATHETER/NEEDLE WERE DISCARDED SO WE DON¿T HAVE PRODUCT TO RETURN, UNFORTUNATELY. 22G NEXIVA CATHETER USED TO START PIV IN RIGHT FOREARM. CATHETER WAS MOSTLY ADVANCED WHEN NEEDLE WAS REMOVED. NOTED BLEEDING FROM SITE. GENTLE PRESSURE HELD AT SITE FOR A FEW SECONDS AND BLEEDING STOPPED. CATHETER FLUSHED WITH NS AND NOTED LEAKING AT SITE. CATHETER PULLED BACK A LITTLE AND NOTED SMALL HOLE IN CATHETER. CATHETER REMOVED AND PIV STARTED IN NEW VEIN. CATHETER WAS BD NEXIVA 22G X1" LOT NUMBER 2182272 REF #383512.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481200 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 2182272 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown