BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST / VAXCEL

    MDR report key: 2072564 · Received April 21, 2011

    Report

    Report Number
    1317056-2011-00042
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 25, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 NAVILYST MEDICAL (B)(4) 2011 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. THE RETURNED CATHETER SAMPLE CONTAINED A HOLE IN THE TUBING JUST DISTAL TO THE SUTURE WING. THE CONDITION OF THE CATHETER INDICATES THAT IT WAS IN-PLACE FOR A PERIOD OF TIME. IF THE CATHETER IS BENT OVER WHERE IT EXITS, THE SUTURE WING, THE HOLE IS AT THE POINT WHERE THE CATHETER KINKS. THE POTENTIAL ROOT CAUSE OF THE DEFECT IS PROLONGED KINKING OF THE CATHETER, USE OF SHARP INSTRUMENTS IN THE VICINITY OF THE CATHETER AND/OR APPLYING THE DRESSING PRIOR TO ALLOWING THE CLEANING AGENT TO FLASH OFF/EVAPORATE. THE DIRECTIONS FOR USE PACKAGED WITH THE PICC DEVICES CONTAINS THE FOLLOWING STATEMENTS: "DO NOT USE CLAMPS OR INSTRUMENTS WITH TEETH OR SHARP EDGES ON THE CATHETER, AS CATHETER DAMAGE MAY OCCUR," AND "PRECAUTION: PRIOR TO DRESSING THE CATHETER AND ACCESS SITE, INSPECT BOTH TO ENSURE THAT THEY ARE COMPLETELY DRY OF ISOPROPYL ALCOHOL OR ACETONE-BASED CLEANING AGENTS." MANUFACTURING PROCESS CONTROLS FOR THE PICC INCLUDE 100% AIR LEAK TESTING TO INSURE THAT ALL CATHETERS ARE FREE OF LEAKS/HOLES. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST'S DISTRIBUTOR IN (B)(4), A LEAK WAS REPORTED IN AN IMPLANTED 4F VALVED PICC DEVICE. THE LEAK WAS NOTED BY A NURSE WHEN THE PICC WAS FLUSHED DURING A NEW HOSPITALIZATION. THE PROCEDURE WAS TO FLUSH FIRST WITH 20ML OF SALINE BEFORE TAKING BLOOD SAMPLES. THERE WAS NO OBSTRUCTION NOTED NOR HIGH PRESSURE USED IN THE PICC LINE WHILE FLUSHING. THE PICC HAD BEEN PLACED AND USED FOR THE FIRST TIME ON (B)(6) 2011, AND WAS REMOVED ON (B)(6), THE DAY THE LEAK WAS NOTICED. THE PATIENT CONDITION WAS NOTED AS "STABLE." THE USED PICC WAS RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST / VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL 4082290

    Patients

    Seq Age Sex Outcome Treatment
    1