BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL / NAVILYST MEDIAL

    MDR report key: 2885313 · Received November 20, 2012

    Report

    Report Number
    1317056-2012-00045
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2012, NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PORT AND THE FAILURE MODE OF "CATHETER FRACTURED." NO ADVERSE TRENDS WERE IDENTIFIED. THE DEVICE SAMPLE WAS RETURNED WITH THE COLLAR INTACT, AND THE CATHETER TUBING STILL ATTACHED TO THE PORT. EXAMINATION OF THE TUBING REVEALED TWO PARALLEL SLICES ORIENTED PERPENDICULAR TO THE CATHETER SHAFT. THESE SLICES WERE LOCATED BETWEEN THE 7-8CM MARKINGS. THE SLICES WERE NOT JAGGED, WHICH WOULD HAVE INDICATED TUBING OVERPRESSURIZATION. RATHER, THE ORIENTATION OF THE SLICES AND THE WIDTH BETWEEN THEM INDICATES THAT THE ROOT CAUSE OF THE DAMAGE IS FORCEPS USED DURING THE PORT REMOVAL PROCEDURE. THIS WOULD BE CONSISTENT WITH THE INFO THAT THE PORT HAD BEEN FUNCTIONING CORRECTLY FOR THE TWO YRS IT HAD BEEN IMPLANTED AND THAT THE DAMAGE TO THE TUBING WAS FIRST NOTICED DURING THE PORT EXPLANT PROCEDURE. THE DIRECTIONS FOR USE PACKAGED WITH THE PORT CAUTIONS AGAINST THE USE OF "INSTRUMENTS WITH TEETH" BEING USED TO GRASP THE CATHETER, AS CATHETER FRACTURE COULD RESULT. NAVILYST MEDICAL MFG PROCESS CONTROLS INCLUDE 100% LEAK TESTING, AS WELL AS DIMENSIONAL INSPECTIONS, STATIC BURST TESTING, AND TENSILE TESTING. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, DURING REMOVAL OF A CHEST PORT, IT WAS NOTED THAT THERE WAS A "CRACK" IN THE CATHETER. THE PORT HAD BEEN PLACED 2 YRS AGO AT A DIFFERENT HOSPITAL, AND WAS BEING REMOVED BECAUSE THE PT NO LONGER REQUIRED CHEMOTHERAPY. THERE WERE NO INJURIES OR COMPLICATIONS TO THE PT BECAUSE OF THE EVENT. THE USED DEVICE WAS RETURNED TO NAVILYST MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL / NAVILYST MEDIAL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1296141

    Patients

    Seq Age Sex Outcome Treatment
    1