BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL/VAXCEL

    MDR report key: 3843624 · Received February 12, 2014

    Report

    Report Number
    1317056-2014-00014
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    December 30, 2013
    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 NOVEMBER 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. ALTHOUGH THE USED DEVICE FROM THIS EVENT WAS DISCARDED AT THE HOSPITAL, A SAMPLE FROM A SIMILARLY REPORTED FAILURE AT THIS HOSP HAS BEEN EVALUATED AND THE LIKELY ROOT CAUSE FOR THE HOLE IN THE CATHETER WAS DETERMINED TO BE FATIGUE DUE TO REPEATED 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 CLEANING 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)(4), A VALVED PICC DEVICE HAD BEEN IMPLANTED INTO A PT ON (B)(6) 2013. ON (B)(6) 2013 IT WAS REMOVED DUE TO A SPLIT IN THE CATHETER TUBING. THERE WAS NO INJURY TO THE PT. THE USED DEVICE WAS DISCARDED AT THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93107 NAVILYST MEDICAL/VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA 4644324

    Patients

    Seq Age Sex Outcome Treatment
    1