BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 15 FR X 23 CM

    MDR report key: 2080112 · Received April 7, 2011

    Report

    Report Number
    1036844-2011-00112
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    MSD
    PMA / PMN Number
    K040666
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PT WITH CHRONIC RENAL FAILURE HAD A CANNON CATHETER INSERTED IN THE OPERATING ROOM IN SEPTEMBER 2010 VIA THE RIGHT INTERNAL JUGULAR. THE DIALYSIS STAFF IN THE NATIONAL RENAL CARE UNIT NOTICED THE CATHETER HAD BUBBLES ON THE SURFACE OF THE MFG MATERIAL ABOUT A WEEK AGO. THE PT CAME IN FOR DIALYSIS ON (B)(6) 2011 AND THERE WAS BLOOD LEAKING FROM THE EXTERNAL PROXIMAL PART OF THE CATHETER. ON CLOSER INSPECTION, THEY SAW THAT ONE OF THESE BUBBLES (WHICH THEY NOTICED A WEEK AGO) HAD BURST OPEN AND WAS NOW LEAKING BLOOD. THE DIALYSIS WAS DELAYED WHILE THE MD REPAIRED THE CATHETER IN THE UNIT BY CUTTING AWAY 5 CM OF THE PROXIMAL PART OF THE CATHETER WHICH CONNECTS TO THE EXTERNAL HUB. HE CONNECTED A NEW REPLACEMENT KIT. THE CATHETER WAS NOW FULLY FUNCTIONAL AND DIALYSIS TOOK PLACE AS PLANNED AND WAS NOT COMPROMISED IN ANY WAY. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 15 FR X 23 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC RF0060720

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK