BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9712190 · Received February 14, 2020

    Report

    Report Number
    1710034-2020-00079
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 23, 2020
    Report Date
    March 31, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED NEXIVA 20GA AND PACKAGE LABEL, FROM MATERIAL NUMBER 383517, LOT NUMBER 9182998. THE NEEDLE SET WAS NOT RETURNED FOR EVALUATION. IN ADDITION, FOUR PHOTOS WERE RECEIVED. UPON VISUAL INSPECTION OF THE UNIT, DAMAGE TO THE TUBING WAS OBSERVED APPROXIMATELY ONE INCH FROM THE NOSE OF THE STRAIGHT ADAPTER. FURTHER INVESTIGATION OF THE DAMAGE TO THE EXTENSION TUBING DISPLAYED A HOLE IN THE TUBING. A LEAKAGE TEST WAS PERFORMED WHERE LEAKAGE WAS OBSERVED AT THE POINT OF DAMAGE. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING EQUIPMENT RELATED ISSUE FOR THE REPORTED DEFECT. 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 LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURED, CONNECTED EX-TUBE AND SALINE OR BLOOD LEAKED FROM THE DAMAGE OF TUBING BETWEEN THE CLUMP AND THE HUB.

    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 LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURED, CONNECTED EX-TUBE AND SALINE OR BLOOD LEAKED FROM THE DAMAGE OF TUBING BETWEEN THE CLUMP AND THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178237 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383517 9182998 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other