BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9586989 · Received January 14, 2020

    Report

    Report Number
    1710034-2020-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 27, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835394
    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: BD RECEIVED ONE USED NEXIVA 18GA DUAL PORT UNIT IN AN OPENED PACKAGE FROM MATERIAL NUMBER 383539, LOT NUMBER 9051988. IN ADDITION, FIVE PHOTOGRAPHS WERE ALSO SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. THROUGH THE VISUAL MICROSCOPIC EVALUATION DAMAGE WAS OBSERVED TO THE GREY CANISTER AND BODILY FLUIDS WERE PRESENT AROUND THE CANISTER. THE PRIMARY SEPTUM WAS PUSHED DOWN OVER PART OF THE GREY CANISTER. A WATER/AIR LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT CONFIRMED THROUGH OUR TESTING. ALTHOUGH LEAKAGE WAS NOT CONFIRMED, IT MAY BE POSSIBLE THAT THE BODILY FLUIDS IN THE DEVICE PREVENTED OUR TESTING FROM CONFIRMING THE DEFECT OF LEAKAGE. THE DAMAGE OBSERVED TO THE GREY CANISTER IS AN OPEN PATH FOR LEAKAGE. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO GRIPPER DAMAGE OR MISALIGNMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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 BLOOD LEAKED FROM SEPTUM DURING USE WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER CATHETER PLACEMENT, BLOOD LEAKED FROM THE CATHETER SEPTUM WHEN DRAWING THE NEEDLE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 BLOOD LEAKED FROM SEPTUM DURING USE WITH A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER CATHETER PLACEMENT, BLOOD LEAKED FROM THE CATHETER SEPTUM WHEN DRAWING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52655 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383539 9051988 30382903835394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other