BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 33/50KT VT

    MDR report key: 4121797 · Received July 28, 2014

    Report

    Report Number
    3009211636-2014-00028
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    COSTA RICA COVIDIEN MANUFACTURING
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 DOCTOR USED THE PALINDROME (LOT 213810X) FOR DIALYSIS TREATMENT, BUT THE PT HAD TO STAY IN AN UNCOMFORTABLE POSITION WHICH RESULTED IN MINIMUM FLOW. THE DOCTOR CHANGED THE CATHETER (LOT 320618X) AND STILL DID NOT WORK. IT SEEMED THAT THE CATHETER WAS KINKING. THE THIRD SURGERY WAS DONE AND A CATHETER WAS INSERTED SPLIT CATH AND WORKED SATISFACTORILY. THE CURRENT STATE OF THE PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440021 PALINDROME SAPPHIRE 33/50KT VT DIALYSIS CATHETER MPB COSTA RICA COVIDIEN MANUFACTURING 8888145050 213810X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK