BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 19/36 KIT W/SLOT

    MDR report key: 3906377 · Received June 5, 2014

    Report

    Report Number
    1317749-2014-00256
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS 297279(JULIAN LOT NUMBER 832726). LOT 297279 WAS RELEASED ON 12/09/08 WITH AN ORDER QUANTITY OF (B)(4) CASES. THE CATHETER ASSEMBLY PART NUMBER 00476036, LOT NUMBER 297196 WAS UTILIZED IN THE PACKAGING LOT. THE DHR REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE.THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITHOUT THE SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS AND IF A TREND IS OBSERVED, ACTIONS WILL BE TAKEN AS NECESSARY. 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. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    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 REPORTS THAT THERE WAS A BLOOD LEAK COMING FROM THE Y JUNCTION OF CATHETER AND THE HUB. CATHETER HAD BEEN INSERTED ON (B)(6) 2009 AND REMOVED (B)(6) 2014. NEW CATHETER WAS INSERTED. NO PATIENT INJURY. THE DEVICE IS NOT BEING RETURNED FOR INVESTIGATION, IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329852 PALINDROME 19/36 KIT W/SLOT DIALYSIS CATHETER MSD COVIDIEN 8888145014 832726

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK