BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT, 20G X 1.75"

    MDR report key: 17358102 · Received July 20, 2023

    Report

    Report Number
    1710034-2023-00816
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 26, 2023
    Report Date
    August 8, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835189
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A USED 20G NEXIVA UNIT. THE EXTENSION TUBING APPEARS DISCOLORED, AND A LONG TEAR CAN BE ON THE EXTENSION TUBING CLOSE TO THE CATHETER ADAPTER END. BASED ON THESE OBSERVATIONS, IT IS LIKELY THAT THE TUBING BALLOONED AND BURST DURING INFUSION. NO KINKS CAN BE SEEN ON THE UNIT; HOWEVER, THE FULL UNIT IS NOT VISIBLE, SO IT STILL REMAINS A POTENTIAL ROOT CAUSE. DURING MANUFACTURING, A BALLOONED TUBING MAY RESULT FROM AN OCCLUSION DUE TO EXCESS ADHESIVE BETWEEN THE CATHETER ADAPTER AND EXTENSION TUBING OR FROM KINKED TUBING. IF AN OCCLUSION WAS PRESENT, THE COMPONENTS WOULD HAVE TO BE PARTIALLY OCCLUDED AS A FULL OCCLUSION WOULD LIKELY CAUSE THE CLINICIAN TO EXPERIENCE ISSUES DURING FLASHBACK AND FLUSHING OF THE DEVICE. ADDITIONALLY, DURING USE, BALLOONING MAY OCCUR DUE TO A KINKED, OCCLUDED, OR OBSTRUCTED TUBING. WITHOUT THE PHYSICAL DEVICE THE ROOT CAUSE COULD NOT BE FURTHER NARROWED DOWN. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT, 20G X 1.75" TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED EXTERNAL TUBING SPLIT IN HALF WHILE INJECTING CT CONTRAST (ISOVUE 370) AT A RATE OF 1.9ML/SEC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA SINGLE PORT, 20G X 1.75" TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED EXTERNAL TUBING SPLIT IN HALF WHILE INJECTING CT CONTRAST (ISOVUE 370) AT A RATE OF 1.9ML/SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736548 BD NEXIVA SINGLE PORT, 20G X 1.75" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383518 2300204 30382903835189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown