BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9835763 · Received March 16, 2020

    Report

    Report Number
    1710034-2020-00174
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 22, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED USED NEXIVA 20GA UNIT WITH A PACKAGE LABEL FROM MATERIAL NUMBER 383536, LOT NUMBER 9233236. A VISUAL/MICROSCOPIC EVALUATION OF THE RETURNED SAMPLE REVEALED THERE WAS A SLIT/CUT IN THE EXTENSION TUBING APPROXIMATELY ¾¿ FROM THE Y ADAPTER. A TEST WAS DONE FOR LEAKAGE WHERE AIR BUBBLES WERE OBSERVED IN THE AREA OF THE SLIT/CUT. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE GRIPPER FINGERS DAMAGING THE CATHETER TUBING AND THE TUBING SLIPPING AND BECOMING MISALIGNED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING WAS SPLIT AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536 BATCH NO.: 9233236 IT WAS REPORTED THAT THE TUBING WAS SPLIT CAUSING BLOOD TO LEAK OUT AND MULTIPLE ATTEMPTS AT IV ACCESS TO THE CRITICAL PATIENT. THE IV WAS INSERTED INTO A TRAUMA PATIENT, AND FOUND TO HAVE A SPLIT IN THE TUBING THROUGH WHICH BLOOD LEAKED OUT AND THE UNIT WAS NOT ABLE TO BE USED. ANOTHER ATTEMPT WAS MADE AT IV ACCESS AND FAILED. THE PATIENT THEN REQUIRED US GUIDED IV PLACEMENT. THERE WAS A SIGNIFICANT DELAY TO IV ACCESS FOR THIS POTENTIALLY CRITICAL PATIENT DUE TO THE DEFECTIVE UNIT. FORTUNATELY THERE WAS NOT BODILY FLUID EXPOSURE TO THE STAFF, BUT IT DID RESULT IN A DELAY AS WELL AS 2 ADDITIONAL ATTEMPTS AT ACCESS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM TUBING WAS SPLIT AND LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536, BATCH NO.: 9233236. IT WAS REPORTED THAT THE TUBING WAS SPLIT CAUSING BLOOD TO LEAK OUT AND MULTIPLE ATTEMPTS AT IV ACCESS TO THE CRITICAL PATIENT. THE IV WAS INSERTED INTO A TRAUMA PATIENT, AND FOUND TO HAVE A SPLIT IN THE TUBING THROUGH WHICH BLOOD LEAKED OUT AND THE UNIT WAS NOT ABLE TO BE USED. ANOTHER ATTEMPT WAS MADE AT IV ACCESS AND FAILED. THE PATIENT THEN REQUIRED US GUIDED IV PLACEMENT. THERE WAS A SIGNIFICANT DELAY TO IV ACCESS FOR THIS POTENTIALLY CRITICAL PATIENT DUE TO THE DEFECTIVE UNIT. FORTUNATELY THERE WAS NOT BODILY FLUID EXPOSURE TO THE STAFF, BUT IT DID RESULT IN A DELAY AS WELL AS 2 ADDITIONAL ATTEMPTS AT ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301738 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9233236 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other