BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8174675 · Received December 18, 2018

    Report

    Report Number
    1710034-2018-00938
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 10, 2018
    Report Date
    February 21, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE EXTENSIONS BECOME DETACHED ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ON 2 OCCASSIONS. H.6. INVESTIGATION: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8232654; REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. SAP (QN) DATABASE REVIEW; THE REVIEW DISCLOSED ONE NO-RELATED QN WAS INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED TWO NEXIVA 18GA UNITS, ONE OPENED PACKAGE AND A PACKAGE LABEL FROM THE CATALOG NUMBER 383519, LOT 8232654. ONE UNIT WAS USED ONE PHOTO WAS SUBMITTED FOR REVIEW. VISUAL/MICROSCOPIC EVALUATION: BOTH UNITS HAD THE EXTENSION TUBING WAS SEPARATED FROM THE CLEAR PORT OF THE WINGED ADAPTER. PHOTOS: THE PHOTO DISPLAYED TWO UNITS WITH THE EXTENSION TUBING SEPARATED FROM THE WINGED ADAPTERS AND DISPLAYED THE PAPER LABEL WITH THE BD LOGO, REF NO., DESCRIPTION, LOT NUMBER AND THE EXPIRATION DATE THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSIONS BECOME DETACHED ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ON 2 OCCASSIONS.

    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 EXTENSIONS BECOME DETACHED ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016625 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other