BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7FR X 2 0CM

    MDR report key: 1943988 · Received December 3, 2010

    Report

    Report Number
    3006425876-2010-00085
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF OCT, THE CATHETER WAS INSERTED VIA LEFT SUBCLAVIAN IN THE OPERATING ROOM. THE POSITION OF THE CATHETER WAS CHECKED WITH X-RAY AND IT SEEMED THE CATHETER WAS IN THE PROPER POSITION. APPROXIMATELY ONE WEEK AFTER THE INSERTION, WHEN HIGH CALORIE INFUSION WAS STARTED, DIFFICULTY INFUSING INTO THE CATHETER WAS REPORTED BY THE NURSE. AT THE CATHETER INSERTION SITE THE INFUSION LEAKED AND THE PT COMPLAINED OF PAIN OF THE SKIN, AS THE SKIN BECAME SWOLLEN. WHEN THE LUMEN WAS FLUSHED WITH A SYRINGE, THE INFUSION WAS EJECTED FROM THE INSERTION SITE. AS A RESULT, THE CATHETER WAS REMOVED AND FLUSHED, BUT BOTH LUMENS HAD NO ISSUES. THE PT'S SWOLLEN SKIN WAS TREATED WITH SUCCESS. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK