BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.25IN HF Y

    MDR report key: 12270659 · Received August 3, 2021

    Report

    Report Number
    1710034-2021-00655
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 26, 2021
    Product Code
    FOZ
    UDI-DI
    00382903835379
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE DEVICE DISPLAYING A BROKEN CATHETER. THE REPORTED ISSUE WAS CONFIRMED. CLOSER VISUAL ANALYSIS OF THE BROKEN SECTION OF THE CATHETER, REVEALED A SMOOTH EDGE WHICH IS INDICATIVE OF CONTACT WITH A SHARP CUTTING INSTRUMENT. MANUFACTURING RELATED CAUSES FOR CATHETER DAMAGE WILL PRODUCE JAGGED AND UNEVEN SURFACES. ADDITIONALLY, OCCLUSION TESTING OF THE RETURNED UNIT WAS ALSO PERFORMED. THE FLUID PATHWAY WAS FOUND TO BE UNOBSTRUCTED AND FLUID ADEQUATELY FLOWED THROUGH THE DEVICE. BASED ON THE AVAILABLE INFORMATION OUR ENGINEERS WERE UNABLE TO ASSOCIATE THE ROOT CAUSE FOR THIS EVENT WITH THE MANUFACTURING PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STAFF REPORT THAT A BD NEXIVA CATHETER IS BROKEN INSIDE IN THE PATIENTS VEIN. THE BD NEXIVA WAS PLACED AT THE EMERGENCY DEPARTMENT. THE ISSUE WAS FIRST IDENTIFIED JUST BEFORE AN OPERATION. WHEN THE NURSE TRIED TO FLUSH AT THE NEXIVA, IT WAS NOT POSSIBLE TO FLUSH AT ALL AND THE NURSE WAS FORCED TO REMOVE THE NEXIVA. WHEN THE NEXIVA WAS REMOVED THE NURSE REALIZED THAT IS WAS BROKEN,-ONLY HALF OF THE CATHETER CAME OUT. THE NURSE WAS LUCKY ENOUGH TO BE ABLE TO TAKE THE REMAINING CATHETER OUT WITH A FORCEPS. THE PATIENT GOT AFTERWARDS A NEW PVK SO HE COULD GET HIS MEDICINE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A STAFF REPORT THAT A BD NEXIVA CATHETER IS BROKEN INSIDE IN THE PATIENTS VEIN. THE BD NEXIVA WAS PLACED AT THE EMERGENCY DEPARTMENT. THE ISSUE WAS FIRST IDENTIFIED JUST BEFORE AN OPERATION. WHEN THE NURSE TRIED TO FLUSH AT THE NEXIVA, IT WAS NOT POSSIBLE TO FLUSH AT ALL AND THE NURSE WAS FORCED TO REMOVE THE NEXIVA. WHEN THE NEXIVA WAS REMOVED THE NURSE REALIZED THAT IS WAS BROKEN,-ONLY HALF OF THE CATHETER CAME OUT. THE NURSE WAS LUCKY ENOUGH TO BE ABLE TO TAKE THE REMAINING CATHETER OUT WITH A FORCEPS. THE PATIENT GOT AFTERWARDS A NEW PVK SO HE COULD GET HIS MEDICINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163929 NEXIVA 20GA 1.25IN HF Y INTRAVASCULAR CATHETER FOZ UNKNOWN 00382903835379

    Patients

    Seq Age Sex Outcome Treatment
    1