BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME EMERALD 23/40SP VT

    MDR report key: 2771418 · Received September 27, 2012

    Report

    Report Number
    1317749-2012-00224
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 7, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THAT THE DIALYSIS NURSE ATTEMPTED TO INITIATE THE PT'S DIALYSIS TREATMENT AND NOTED A LEAK IN THE CVC. THE TREATMENT WAS NOT GIVEN DUE TO THE POTENTIAL FOR AIR EMBOLISM AND INFECTION AND THE PT WAS SENT TO THE EMERGENCY ROOM DEPARTMENT FOR FURTHER ASSESSMENT AND EVAL BY THE NEPHROLOGIST ON CALL. THE PT WAS SENT TO ANGIOGRAPHY AND A NEW CVC WAS EXCHANGED UNDER FLUOROSCOPY. THE FAULTY CVC WAS SAVED, UPON INSPECTION THERE IS A VISIBLE SLICE THAT ENCOMPASSES 2/3 OF THE PORT ABOVE THE DISTAL LUER LOCK. ALSO, THE PROXIMAL LUER LOCK CAN ACTUALLY BE PHYSICALLY AND EASILY REMOVED FROM THE PORT. ANOTHER DEVICE WAS USED W/O FURTHER CONSEQUENCE. THERE WAS NO PT INJURY OR ILL-EFFECTS. THE PT'S CURRENT STATUS WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME EMERALD 23/40SP VT DIALYSIS CATHETER MPB COVIDIEN 8888123405 825777

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR