BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL/VAXCEL

    MDR report key: 3843608 · Received February 12, 2014

    Report

    Report Number
    1317056-2014-00008
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 15, 2014
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE (B)(4) 2013 NAVILYST MEDICAL COMPLAINT REPORT WAS PERFORMED FOR THE PRODUCT FAMILY OF VAXCEL PASV PICC AND THE FAILURE MODE OF "HOLE DISTAL TO THE SUTURE WING." NO ADVERSE TRENDS WERE IDENTIFIED. A VISUAL INSPECTION CONFIRMED A HOLE IN THE CATHETER SHAFT JUST DISTAL FROM THE SUTURE WING. THE HOLE WAS A SLIT, STRAIGHT IN APPEARANCE AND ORIENTED PERPENDICULAR TO THE CATHETER SHAFT. THE CATHETER TUBING WAS KINKED IN THIS LOCATION WITH THE HOLE/SLIT BEING IN THE INSIDE CREASE OF THE KINK. THIS TUBING FAILURE IS CONSISTENT WITH A CATHETER THAT WAS REPEATEDLY KINKED AND THE HOLE DEVELOPED DUE TO FATIGUE IN THE KINKED AREA. WHEN THE CATHETER TUBING WAS CROSS-SECTIONED, NO ABNORMALITIES OR THIN SPOTS WERE FOUND IN THE AREA OF THE SPLIT AND THE ID AND OD OF THE CATHETER WERE WITHIN SPECIFICATION. THE MOST LIKELY ROOT CAUSE FOR THE HOLE IN THE CATHETER TUBING IS FATIGUE DUE TO REPEATING KINKING. THE ROOT CAUSE OF THE REPEATED KINKING IS LIKELY DUE TO THE LENGTH OF CATHETER TUBING LEFT EXTERNAL FROM THE INSERTION SITE DURING PLACEMENT AND POSITION OF THE CATHETER SECUREMENT ACCESSORY (E.G. STATLOCK). A CONTRIBUTING FACTOR MAY ALSO INCLUDE NOT ALLOWING CLEANSING AGENTS (ISOPROPYL ALCOHOL OR ACETONE BASED) TO COMPLETELY DRY PRIOR TO COVERING DURING DRESSING CHANGES. MFG PROCESS CONTROLS IN PLACE FOR THE PICC DEVICE INCLUDES IN-PROCESS VISUAL INSPECTION FOR DAMAGE OR DEFECTS, AS WELL AS 100% AIR LEAK TESTS AND GUIDEWIRE INSERTION CHECKS FOR LUMEN PATENCY. INCOMING INSPECTION PROCESS CONTROLS FOR THE PICC CATHETER TUBING INCLUDE VISUAL INSPECTION AS WELL AS A GUIDEWIRE INSERTION CHECK FOR LUMEN PATENCY. THE VAXCEL PASV PICC DFU (DIRECTIONS FOR USE) THAT IS SUPPLIED WITH THE REPORTED DEVICE PROVIDES GUIDELINES, PRECAUTIONS AND WARNINGS THAT SHOULD BE FOLLOWED BY THE END USER IN ORDER TO PROLONG THE USABLE LIFE OF THE CATHETER AND TO REDUCE THE RISK OF DAMAGING THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DIST IN THE (B)(6), A VALVED PICC DEVICE HAD BEEN IMPLANTED INTO A PT ON (B)(6) 2013. ON (B)(6) 2014, IT WAS REMOVED DUE TO A SPLIT IN THE CATHETER TUBING. THERE WAS NO INJURY TO THE PT. THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93347 NAVILYST MEDICAL/VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA 4658391

    Patients

    Seq Age Sex Outcome Treatment
    1