BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7063686 · Received November 28, 2017

    Report

    Report Number
    1710034-2017-00458
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    September 18, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, THE EDGES OF THE REMAINING CATHETER TUBING WERE OBSERVED TO BE SMOOTH. SMOOTH EDGES ARE INDICATIVE OF A SHARP INSTRUMENT CUTTING THE TUBING. HAD THE TUBING BEEN NICKED, POSSIBLY DURING THE MANUFACTURING PROCESS, AND TORN DUE TO ACTUATION OF THE TUBING WHILE THE DEVICE REMAINED IN THE PATIENT, THE TUBING WOULD DISPLAY SIGNIFICANT JAGGEDNESS AND ROUGHNESS ON THE EDGES. THE REPORTED DEFECT WAS NOT CREATED DURING THE MANUFACTURING PROCESS. HAD THE TUBING SUSTAINED THE OBSERVED DAMAGED DURING THE MANUFACTURING PROCESS, THE UNIT WOULD NOT HAVE PASSED THE 100% VISION INSPECTION FOR LIE DISTANCE (THE DISTANCE BETWEEN THE TIP OF THE CATHETER AND THE BEVEL OF THE CANNULA) SINCE THE TUBING WOULD HAVE COMPLETELY SEPARATED FROM THE REST OF THE DEVICE IMMEDIATELY AFTER BEING CUT. FURTHERMORE, THIS DAMAGE OCCURRED TO THE DEVICE AFTER INSERTION INTO THE PATIENT'S VASCULATURE, OTHERWISE THE DEVICE WOULD NOT HAVE BEEN SUCCESSFULLY INSERTED WITHOUT NOTICEABLE LEAKAGE. DHR REVIEW - AS NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER, A DHR REVIEW COULD NOT BE PERFORMED FOR THE RETURNED UNIT. QN DATABASE REVIEW - AS NO BATCH NUMBER WAS PROVIDED BY THE CUSTOMER, A QN DATABASE REVIEW COULD NOT BE PERFORMED FOR THE RETURNED UNIT. EURA REVIEW - INVESTIGATION HAS SHOWN THAT THE CATHETER TUBING WAS CUT. THE FAILURE MODE OF CATHETER CUT HAS BEEN IDENTIFIED IN (B)(4). BASED ON THE CUSTOMER'S VERBATIM DESCRIPTION, THE EFFECT OF THIS FAILURE MODE IS CATHETER FRAGMENT REQUIRING SURGICAL REMOVAL, WHICH HAS A MODERATE SEVERITY OF S3. OCCURRENCE RATE OF THIS DEFECT COULD NOT BE ESTABLISHED FOR THE BATCH AS NO BATCH NUMBER WAS PROVIDED. HOWEVER, GIVEN A REMOTE OCCURRENCE (RARELY, IF EVER, OBSERVED) AND A MODERATE SEVERITY, THE RISK TO THE END USER IS ACCEPTABLE. (B)(4) HAS BEEN CREATED TO CLARIFY THE REMOVAL STEP AND ASSOCIATED RISKS. SAMPLE ANALYSIS - VISUAL/MICROSCOPIC EXAMINATION REVEALED THAT THE EDGES OF THE REMAINING CATHETER TUBING WERE SMOOTH . SMOOTH EDGES ARE INDICATIVE OF A SHARP INSTRUMENT CUTTING THE TUBING. THE CUSTOMER'S EXPERIENCE WAS CONFIRMED BY THE RETURNED UNIT. CONCLUSION: THE SMOOTH EDGES OF THE REMAINING CATHETER TUBING INDICATE THAT THE ENTIRE WALL THICKNESS OF THE TUBING WAS CUT WITH A SHARP EDGE AROUND THE ENTIRE DIAMETER OF THE TUBING. HAD THE TUBING BEEN NICKED, POSSIBLY DURING THE MANUFACTURING PROCESS, AND TORN DUE TO ACTUATION OF THE TUBING WHILE THE DEVICE REMAINED IN THE PATIENT, THE TUBING WOULD DISPLAY SIGNIFICANT JAGGEDNESS AND ROUGHNESS ON THE EDGES. THE REPORTED DEFECT WAS NOT CREATED DURING THE MANUFACTURING PROCESS. HAD THE TUBING SUSTAINED THE OBSERVED DAMAGED DURING THE MANUFACTURING PROCESS, THE UNIT WOULD NOT HAVE PASSED THE 100% VISION INSPECTION FOR LIE DISTANCE (THE DISTANCE BETWEEN THE TIP OF THE CATHETER AND THE BEVEL OF THE CANNULA) SINCE THE TUBING WOULD HAVE COMPLETELY SEPARATED FROM THE REST OF THE DEVICE IMMEDIATELY AFTER BEING CUT. FURTHERMORE, THIS DAMAGE OCCURRED TO THE DEVICE AFTER INSERTION INTO THE PATIENT'S VASCULATURE, OTHERWISE THE DEVICE WOULD NOT HAVE BEEN SUCCESSFULLY INSERTED WITHOUT NOTICEABLE LEAKAGE. D16123 REV 6(C) NEXIVA DUAL PORT INSTRUCTIONS FOR USE PRECAUTIONS AGAINST USING SCISSORS OR SHARP INSTRUMENTS AT OR NEAR THE INSERTION SITE.

    Additional Manufacturer Narrative · 1

    .THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE RECEIVED BY MANUFACTURER. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 11/27/2017.

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THE BD NEXIVA CLOSED IV CATHETER SYSTEM HAD THE ¿CATHETER BREAKING IN TWO, IT HAD TO BE SURGICALLY REMOVED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843919 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention