BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME CATHETER

    MDR report key: 2030318 · Received March 21, 2011

    Report

    Report Number
    1317749-2011-00098
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ARGYLE (SHERIDAN)
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE PATIENT CAME INTO IR FOR PALINDROME CATHETER EXCHANGE DUE TO BUBBLES APPEARING ON THE OUTER LUMEN OF THE CATHETER NEAR THE CUFF. THE CATHETER WAS REMOVED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME CATHETER HEMODIALYSIS CATHETER MPB ARGYLE (SHERIDAN) UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK