BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN INSERTION TRAY

    MDR report key: 2082119 · Received April 26, 2011

    Report

    Report Number
    1317749-2011-00137
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 04/25/2011. 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 SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTS THAT A PICC WAS PLACED AND 3 DAYS AFTER INSERTION, THE PICC WAS NOTICED TO BE LEAKING JUST BELOW THE MOLDED STRAIN RELIEF ON THE EXTENSION TUBING. THE CUSTOMER REPORTS THE PICC WAS REPLACED WITH ANOTHER PICC. THE CUSTOMER REPORTS THAT THE PATIENT LATER DIED; HOWEVER, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE OF PATIENT DEATH OR THE LENGTH OF TIME BETWEEN THE DESCRIBED EVENT AND THE PATIENT' DEATH. THE CUSTOMER FURTHER STATED THAT THERE IS NO CORRELATION BETWEEN THE PICC AND THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LUMEN INSERTION TRAY PICC LJS COVIDIEN 43309 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN