BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM)

    MDR report key: 8664737 · Received June 3, 2019

    Report

    Report Number
    1710034-2019-00588
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. CONCLUSION(S): RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED CATHETER INFILTRATION/EXTRAVASATION, CAUSING A SERIOUS INJURY IN THE FORM OF INFILTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383511, BATCH NO. 9053857. WE USE YOUR 24 GA 0.75 IN 0.7 X 19 MM CATHETER IN OUR INFUSION ROOM. RECENTLY WE HAVE HAD SEVERAL PATIENTS INFILTRATE AND I AM WONDERING IF THERE POSSIBLY COULD BE AN ISSUE WITH THE CATHETER ITSELF. WE HAVE USED THESE FOR SEVERAL YEARS AND THE SAME PERSON IS STARTING IVS WITH THEM. THE CATHETER INFILTRATED INTRAVASCULARLY. THERE WAS NO LEAKAGE OF BLOOD OR BODY FLUID OUTSIDE OF THE BODY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT A BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) EXPERIENCED CATHETER INFILTRATION/EXTRAVASATION, CAUSING A SERIOUS INJURY IN THE FORM OF INFILTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 9053857. WE USE YOUR 24 GA 0.75 IN 0.7 X 19 MM CATHETER IN OUR INFUSION ROOM. RECENTLY WE HAVE HAD SEVERAL PATIENTS INFILTRATE AND I¿M WONDERING IF THERE POSSIBLY COULD BE AN ISSUE WITH THE CATHETER ITSELF. WE HAVE USED THESE FOR SEVERAL YEARS, AND THE SAME PERSON IS STARTING IVS WITH THEM. THE CATHETER INFILTRATED INTRAVASCULARLY. THERE WAS NO LEAKAGE OF BLOOD OR BODY FLUID OUTSIDE OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458577 BD NEXIVA SINGLE PORT 24GA 0.75IN (0.7 MM X 19 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9053857 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other