BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL / VAXCEL

    MDR report key: 2251162 · Received August 10, 2011

    Report

    Report Number
    1317056-2011-00081
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 22, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. THE (B)(4) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PICCS AND THE FAILURE MODE OF "HOLE IN CATHETER." NO ADVERSE TRENDS WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED FOR EVAL, THE COMPLAINT COULD NOT BE CONFIRMED, NOR COULD A ROOT CAUSE BE DETERMINED. A POTENTIAL ROOT CAUSE OF THE DEFECT MAY BE PROLONGED KINKING OF THE CATHETER, USE OF SHARP INSTRUMENTS IN THE VICINITY OR THE CATHETER AND/OR APPLYING THE DRESSING PRIOR TO ALLOWING THE CLEANING AGENT TO FLASH OFF. THE 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. MFG PROCESS CONTROLS FOR THE CATHETER ASSEMBLY INCLUDE IN-PROCESS VISUAL INSPECTION FOR SCRATCHES, KINKS OR CRACKS, 100% AIR LEAK TESTING AND ALL DEVICES, AND A GUIDEWIRE CHECK FOR LUMEN PATENCY. ((B((4)).

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL, A 4F VALVED PICC DEVICE HAD BEEN IMPLANTED FOR 10 DAYS IN THE NICU DEPT WHEN THE CATHETER FRACTURED DISTAL TO THE SUTURE WING AT APPROX THE "0" LOCATION MARKING. THERE WERE NO COMPLICATIONS TO THE PT. THE USED DEVICE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJT NAVILYST MEDICAL NA 4100214

    Patients

    Seq Age Sex Outcome Treatment
    1