BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20CM SCHON XL DOUBLELUMEN CATHETER

    MDR report key: 6515244 · Received April 24, 2017

    Report

    Report Number
    1319211-2017-00043
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    July 25, 2016
    Report Date
    April 21, 2017
    Manufacturer
    MARTECH MEDICAL PRODUCTS
    Product Code
    MSD
    UDI-DI
    H787108007025
    PMA / PMN Number
    K971925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS NOTIFIED THE DIALYSIS CATHETER MANUFACTURER OF THIS COMPLAINT EVENT ON JULY 28, 2016 VIA SUPPLIER CORRECTIVE ACTION REQUEST (B)(4). AS PART OF A REVIEW OF COMPLAINTS RELATED TO DISTRIBUTION ONLY PRODUCTS, ANGIODYNAMICS IDENTIFIED THAT IT DOES NOT HAVE OBJECTIVE EVIDENCE THAT THE MANUFACTURER ASSESSED THIS COMPLAINT EVENT FOR MDR REPORTABILITY. AS A RESULT OF THIS REVIEW, ANGIODYNAMICS CHOSE TO ASSESS THIS COMPLAINT EVENT FOR REPORTABILITY AND DETERMINED THAT IT DOES MEET THE CRITERIA TO FILE AN MDR. THIS RETROSPECTIVE MDR IS BEING FILED BASED ON THIS REVIEW AND TO ENSURE COMPLAINT FILE IS COMPLETE. ONE SCHON DIALYSIS WAS RETURNED FOR EVALUATION AND FORWARDED TO OUR VENDOR FOR EVALUATION. THE REPORTED DIALYSIS CATHETER HAS BEEN RETURNED TO ANGIODYNAMICS. ANGIODYNAMICS HAS FORWARDED THE DEVICE TO THE SUPPLIER FOR AN EVALUATION AND MANUFACTURING REVIEW. PER ANGIODYNAMICS' VENDOR RESPONSE, A HOLE WAS NOTED IN THE VENOUS EXTENSION. THE CUSTOMERS REPORTED COMPLAINT OF A HOLE IN THE BLUE PORT IS CONFIRMED. A REVIEW OF THE INCOMING LOT HISTORY RECORDS WAS PERFORMED FOR THE VENDOR LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION. THOUGH A ROOT CAUSE WAS NOT SPECIFIED BY THE MANUFACTURER, A POTENTIAL CONTRIBUTING FACTOR COULD BE IF THE CLAMPS WERE REPEATEDLY CLOSED AT THE SAME LOCATION ON THE EXTENSION TUBING. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, STATES: "CLAMPING THE CATHETER REPEATEDLY IN THE SAME SPOT COULD WEAKEN THE TUBING. CHANGE THE POSITION OF THE CLAMPS REGULARLY TO PROLONG THE LIFE OF THE TUBING." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4). DEVICE NOT MFD. BY REPORTING FIRM.

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: DURING A DIALYSIS PROCEDURE, IT WAS NOTED THE DIALYSIS CATHETER WAS LEAKING. THE CATHETER WAS REMOVED AND SET ASIDE. A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297008 20CM SCHON XL DOUBLELUMEN CATHETER SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS MSD MARTECH MEDICAL PRODUCTS MHDA660 H787108007025

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR