BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALIND 23 SLOT SPRT W/VT

    MDR report key: 3983566 · Received June 26, 2014

    Report

    Report Number
    1317749-2014-00278
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE RETURNED CONSISTED OF ONE PALINDROME 23/40 SLOT SPORT W/VT CATHETER. AFTER VISUAL INSPECTION, SIGNS OF USAGE (BLOOD RESIDUES) WERE IDENTIFIED. THE FELT CUFF WAS NOT ATTACHED TO THE CATHETER. RESIDUES OF GLUE ON THE FELT CUFF AREA WERE DETECTED. THE POSSIBLE CAUSES WERE IDENTIFIED. NO LOT NUMBER WAS PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DHR REVIEW. THIS DEFECT HAS BEEN CONFIRMED. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE RELATED TO THE EJECTION/SUBTRACTION METHOD THE CUSTOMER IS EMPLOYING TO REMOVE THE DEVICE FROM THE PATIENT. NO ADDITIONAL ACTIONS ARE REQUIRED. THIS FAILURE IS NOT CONSIDERED 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% VISUAL INSPECTION DURING PRODUCTION, WHICH WOULD IDENTIFY CUFF DEFECTS IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRENDING AND TRACKING PURPOSES.

    Additional Manufacturer Narrative · 1

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

    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 THE CUFF DETACHED FROM THE CATHETER UPON REMOVAL. ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE CUFF FROM THE BODY. THE DEVICE WAS IMPLANTED IN THE PATIENT FOR 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375293 PALIND 23 SLOT SPRT W/VT DIALYSIS CATHETER MPB COVIDIEN LP 8888123404 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK