BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/ SLOT

    MDR report key: 4221154 · Received November 3, 2014

    Report

    Report Number
    3009211636-2014-00140
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 25, 2014
    Report Date
    October 25, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO WAS PROVIDED BY THE CUSTOMER. THE IMAGE SHOWS THE CATHETER TUBING WITH ITS CUFF MISSING. THE REMAINING GLUE AND SOME CUFF FELT CAN BE SEEN ON THE CATHETER. AS PER THE INSTRUCTIONS FOR USE, IT IS NECESSARY TO PERFORM A VISUAL INSPECTION BEFORE USING THE DEVICE. DO NOT USE THE CATHETER IF IT APPEARS DAMAGED OR DEFECTIVE. THE CATHETER TUBING CAN TEAR WHEN SUBJECTED TO EXCESSIVE FORCE OR ROUGH EDGES. DO NOT USE A SHARP, JERKING MOTION OR UNDUE FORCE; THIS MAY TEAR THE CATHETER. IT IS IMPORTANT TO FREE THE CUFF AND SURFACES FROM THE TISSUE PRIOR TO REMOVAL. THE PHOTO GIVEN BY THE CUSTOMER PROVIDES EVIDENCE TO CONFIRM THE ISSUE. THE IMAGE SAMPLE SHOWS EVIDENCE OF CUFF ADHERENCE AS IT PRESENTS FELT FILAMENTS AND GLUE RESIDUE IN A VERY OBSERVABLE LEVEL. THE EVENT DESCRIPTION STATED THAT THE CATHETER WAS TESTED PRIOR TO USE AND ADDITIONALLY FUNCTIONED AS INTENDED FOR EIGHT (8) MONTHS, THEREFORE IT CAN BE CONCLUDED THAT THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE WOULD BE DUE TO EXCESSIVE FORCE OR A JERKING MOTION. HOWEVER WITHOUT FURTHER INFORMATION, THIS CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. THE DHR REVIEW INDICATED THAT THERE WERE NO QUALITY ISSUES ASSOCIATED WITH THIS REPORTED CONDITION. 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. AS PER PROCEDURE, MANUFACTURING PERFORMS 100% VISUAL AND DIMENSIONAL INSPECTION AND 100% ASSEMBLY FINAL INSPECTION RESPECTIVELY, WHICH WOULD IDENTIFY CUFF DEFECTS IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT CUFF SEPARATED FROM THE CATHETER. AFTER 8 MONTHS, THE CATHETER FELL OUT OF THE PATIENT'S BODY. THE PRODUCT WAS TESTED PRIOR TO USE. THE CATHETER WAS REPLACED WITH A NEW ONE. NO REPORT OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702636 PALINDROME 19/36 KIT W/ SLOT DIALYSIS CATHETER MSD COSTA RICA 8888145014 212420X

    Patients

    Seq Age Sex Outcome Treatment
    1