BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHON XL DOUBLE LUMEN CATHETER

    MDR report key: 6556401 · Received May 10, 2017

    Report

    Report Number
    1319211-2017-00048
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    August 15, 2016
    Report Date
    July 17, 2017
    Manufacturer
    MARTECH MEDICAL PRODUCTS
    Product Code
    MSD
    UDI-DI
    H787108007025
    PMA / PMN Number
    K971925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS NOTIFIED THE DIALYSIS CATHETER MANUFACTURER OF THIS COMPLAINT EVENT ON APRIL 26, 2017 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. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMERS REPORTED COMPLAINT OF A HOLE IN THE CATHETER COULD NOT BE CONFIRMED BECAUSE NO SAMPLE WAS RECEIVED FOR EVALUATION. WITHOUT A DEVICE EVALUATION, ANGIODYNAMICS IS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE EVENT. ANGIODYNAMICS' SUPPLIER WAS NOTIFIED OF THIS EVENT VIA (B)(4). THE SUPPLIER PROVIDED A DHR REVIEW THAT NOTED NO ABNORMALITIES DURING THE PRODUCTION OF THE DEVICE. THE INCOMING RECEIVER LOT RECORD AND THE VENDOR MANUFACTURING LOT RECORDS BOTH INDICATE THAT ALL DEVICE SPECIFICATION AND QUALITY REQUIREMENTS WERE MET. 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).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON APRIL 25, 2017 VIA A USER MEDWATCH MW5068931: DURING A DIALYSIS PROCEDURE, A HOLE IN THE PATIENT'S DIALYSIS CATHETER WAS NOTED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE USER MEDWATCH DID NOT CONTAIN ANY IDENTIFYING COMPLAINANT CONTACT INFORMATION. A SEARCH OF THE PROVIDED LOT NUMBER REVEALED THE REPORTED LOT HAD BEEN SHIPPED TO MULTIPLE MEDICAL FACILITIES, THEREFORE ANGIODYNAMICS IS UNABLE TO IDENTIFY THE REPORTING COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338059 SCHON XL DOUBLE LUMEN CATHETER SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS MSD MARTECH MEDICAL PRODUCTS MHMD760 H787108007025

    Patients

    Seq Age Sex Outcome Treatment
    1