BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME RT 15FR 23CM KIT

    MDR report key: 1884823 · Received October 25, 2010

    Report

    Report Number
    1317749-2010-00289
    Event Type
    Other
    Date Received
    October 25, 2010
    Report Date
    October 4, 2010
    Manufacturer
    COVIDIEN
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RISK OF AIR EMBOLISM; SUTURING. (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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS DURING INSERTION OF THE CATHETER, THE CATHETER PULLED OFF OF THE TUNNELER WHILE IN THE TUNNEL TRACT. THE CUSTOMER REPORTS HE REMOVED THE ONE APPLIED CLAMP IN ORDER TO QUICKLY GRASP THE TIP OF THE CATHETER TO PULL IT THROUGH THE TUNNEL TRACT (THUS LEAVING NO CLAMPS ON THE CATHETER). THE CUSTOMER REPORTS HE FEELS THE PT IS AT RISK FOR AIR EMBOLISM DURING THIS MANEUVER OF REMOVING/RELOCATING THE CLAMP. THE CUSTOMER THEN PULLED THE CATHETER BACK AND RE-TUNNELED A LARGER TRACT SO THAT HE COULD PUSH THE CATHETER THROUGH THE TRACT AND NOT HAVE IT DETACH. THE LARGER EXIT SITE WAS THEN SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME RT 15FR 23CM KIT HEMODIALYSIS CATHETER MSD COVIDIEN 8888541023 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other