BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT WITH SLOT

    MDR report key: 3940707 · Received April 22, 2014

    Report

    Report Number
    3009211636-2014-00004
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE SECTION FOR INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE POSTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT 3 MONTHS POST PLACEMENT, CRACKS WERE FOUND ON THE ARTERIAL ADAPTER. THE CLINICIAN PULLED AND REPLACED THE CATHETER ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE SAMPLE CONSISTED OF ONE RED ADAPTER WITH A CRACK ON THE SIDE. THE POSSIBLE CAUSES WERE IDENTIFIED. THE DHR WAS REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NOT NCR RELATED TO THE REPORTED ISSUE. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS (B)(4). OVER TIGHTENING CATHETER CONNECTIONS CAN CRACK THE ADAPTERS. THE EVENT DESCRIPTION STATES THE DEVICE WAS IN USE DURING APPROXIMATELY 3 MONTHS, MOST LIKELY, BASED ON THE AVAILABLE INFORMATION, THE DEVICE COULD HAVE BEEN DAMAGED DURING THAT TIME. SAMPLES WERE RECEIVED AND ANALYZED; THIS DEFECT WAS CONFIRMED. BASED ON THE AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE DUE TO A POSSIBLE ADAPTER OVER TIGHTENING, THEREFORE THIS FAILURE IS NOT CONSIDERED AS MANUFACTURING RELATED. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. PER PROCEDURE, MANUFACTURING PERFORMS 100% ADAPTERS INSPECTION FOR CRACKS AND PRESSURE TESTING RESPECTIVELY AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY ADAPTERS ISSUES IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242621 PALINDROME 19/36 KIT WITH SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145014 229905X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK