BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 11750598 · Received April 29, 2021

    Report

    Report Number
    1710034-2021-00354
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED INTO THE PATIENTS BED AT THE END OF THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT HAD WORKING PIV (22G BD NEXIVA) THAT FLUSHED PERFECTLY WITH BLOOD RETURN, MG WAS INFUSING. RN/MOTHER NOTICED LEAKING AROUND THE PIV SITE AND INTO THE BED TOWARDS THE END OF THE INFUSION. WHEN ASSESSED AND FLUSHED, IT WAS FOUND THAT THE PIV WAS LEAKING FROM WHERE THE BLUE TIP OF THE PIV CONNECTED TO THE CLEAR TUBING OF THE PIV. RN CALLED VAT TO COME ASSESS AT THE BEDSIDE. UNFORTUNATELY BECAUSE THERE WAS NO T-CONNECTOR THE PIV HAD TO COME OUT AND A NEW ONE WAS PLACED. PER VAT REQUEST RN SAFETY SCOOPED TO DRAW AWARENESS TO POTENTIAL PRODUCT MALFUNCTION."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED INTO THE PATIENTS BED AT THE END OF THE INFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT HAD WORKING PIV (22G BD NEXIVA) THAT FLUSHED PERFECTLY WITH BLOOD RETURN, MG WAS INFUSING. RN/MOTHER NOTICED LEAKING AROUND THE PIV SITE AND INTO THE BED TOWARDS THE END OF THE INFUSION. WHEN ASSESSED AND FLUSHED, IT WAS FOUND THAT THE PIV WAS LEAKING FROM WHERE THE BLUE TIP OF THE PIV CONNECTED TO THE CLEAR TUBING OF THE PIV. RN CALLED VAT TO COME ASSESS AT THE BEDSIDE. UNFORTUNATELY BECAUSE THERE WAS NO T-CONNECTOR THE PIV HAD TO COME OUT AND A NEW ONE WAS PLACED. PER VAT REQUEST RN SAFETY SCOOPED TO DRAW AWARENESS TO POTENTIAL PRODUCT MALFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646533 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 UNKNOWN 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1