BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9355489 · Received November 21, 2019

    Report

    Report Number
    1710034-2019-01238
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED FOR EVALUATION. 2 PHOTOS WERE RECEIVED. PHOTO #1 DISPLAYS A BOARD WITH THE NURSE INFORMATION. PHOTO # 2 DISPLAYS A 20GA BD NEXIVA PKG. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED IN THE ABSENCE OF A SAMPLE. CONCLUSION(S): THE DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CATHETER KINKED CAUSING AN INABILITY TO DELIVER MEDICATION WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER KINKED UP CAUSING AN INABILITY FOR THE MEDICATION TO PUSH THROUGH UNTIL RESET. ADDITIONALLY, THE PATIENT/COMPANY REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: MY NURSE PROVIDED ME WITH AN IV. I RECEIVED FLUIDS AND MEDICATION VIA THE IV. THEY DISCONNECTED THE IV FROM THE DRIP AND IT WAS JUST IN MY ARM. TRAINEE ATTEMPTED TO ADMINISTER MEDICATION DIRECTLY INTO THE IV AND THE MEDICATION WOULD NOT PUSH IN. NURSE TOOK OVER AND SAID, ¿THESE ALWAYS KINK UP¿..THE MEDICS ARE HAVING TROUBLE WITH THEM TOO¿..I DONT KNOW IF THEY ARE USING CHEAPER PRODUCTS OR WHAT¿¿..¿ SHE SLIGHTLY REMOVED THE IV AND RE-SET IT AND THEN THE MEDICATION WAS ABLE TO PUSH THROUGH.

    Additional Manufacturer Narrative · 1

    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 DURING USE THE CATHETER KINKED CAUSING AN INABILITY TO DELIVER MEDICATION WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER KINKED UP CAUSING AN INABILITY FOR THE MEDICATION TO PUSH THROUGH UNTIL RESET. ADDITIONALLY, THE PATIENT/COMPANY REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: MY NURSE PROVIDED ME WITH AN IV. I RECEIVED FLUIDS AND MEDICATION VIA THE IV. THEY DISCONNECTED THE IV FROM THE DRIP AND IT WAS JUST IN MY ARM. TRAINEE ATTEMPTED TO ADMINISTER MEDICATION DIRECTLY INTO THE IV AND THE MEDICATION WOULD NOT PUSH IN. NURSE TOOK OVER AND SAID, ¿THESE ALWAYS KINK UP¿..THE MEDICS ARE HAVING TROUBLE WITH THEM TOO¿..I DON¿T KNOW IF THEY ARE USING CHEAPER PRODUCTS OR WHAT¿¿..¿ SHE SLIGHTLY REMOVED THE IV AND RE-SET IT AND THEN THE MEDICATION WAS ABLE TO PUSH THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154112 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9182998 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other