BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN

    MDR report key: 9779021 · Received March 3, 2020

    Report

    Report Number
    1710034-2020-00131
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 6, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-03-09. H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE USED 22GA 1.00IN NEXIVA CLOSED IV CATHETER SYSTEM ¿ DUAL PORT UNIT WITHIN AN UNDAMAGED OPENED PACKAGE FROM LOT NUMBER 9233261, REFERENCE NUMBER 383532. THE UNIT CONSISTS OF THE CATHETER/WINGED ADAPTER AND EXTENSION TUBING ASSEMBLIES WITH THE PINCH CLAMP FULLY ENGAGED AND THE NEEDLE COVER ATTACHED. THERE WAS ONE Q-SYTE ATTACHED TO THE END OF ONE OF LUER ADAPTER PORTS AND NO ATTACHMENT ON THE SECOND PORT. THERE WERE TRACES OF DRIED MEDIA THROUGHOUT THE UNIT. THROUGH THE VISUAL MICROSCOPIC EVALUATION DAMAGE WAS OBSERVED ON THE EXTENSION TUBING. THE DAMAGED TUBING SHOWS TO BE COMPRESSED AT OPPOSITE SIDES. A WATER/AIR LEAK TEST WAS PERFORMED ON THE UNIT RESULTING IN CONFIRMATION OF SUCCESSFUL FLOW THROUGH WHICH INDICATES THERE IS NO OBSTRUCTION. THE TEST ALSO CONFIRMED THERE WAS NO LEAKAGE WHICH INDICATES THERE TO BE NO FUNCTIONAL DAMAGE TO THE EXTENSION TUBING. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED. BASED ON THE INVESTIGATION OF THE RECEIVED SAMPLE IT WAS CONFIRMED THAT THE COMPRESSED AREA OBSERVED IN THE EXTENSION TUBING WAS A RESULT OF THE TUBING BEING PINCHED BETWEEN PINCH CLAMP FOR AN EXTENDED PERIOD. 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 THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN EXPERIENCED KINKED TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT APPEARS THE EXTENSION LINE HAS A KINK IN IT. THIS CAUSED THE CANNULA TO BLOCK AND HAD TO BE REPLACED. EVEN IF THIS WAS CAUSED BY THE CLAMP IT SHOULDNT PUT A DENT IN THE LINE. SAMPLE AVAILABLE TO BE RETURNED.

    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 THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN EXPERIENCED KINKED TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT APPEARS THE EXTENSION LINE HAS A KINK IN IT. THIS CAUSED THE CANNULA TO BLOCK AND HAD TO BE REPLACED. EVEN IF THIS WAS CAUSED BY THE CLAMP IT SHOULDN'T PUT A DENT IN THE LINE. SAMPLE AVAILABLE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246488 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 22 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383532 9200876 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other