BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 5 FR X 55 CM

    MDR report key: 2052033 · Received March 2, 2011

    Report

    Report Number
    1036844-2011-00072
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    K930129
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ACCESSED VIA CLOSED SYSTEM, AIR WAS FREELY ASPIRATED FROM THE LINE THAT WAS PLACED IN THE PT'S RIGHT ARM IN THE POST ANESTHESIA CARE UNIT. THE PT WAS A 70 YEAR OLD MALE OUTPATIENT AND HAD COME TO THE HOSPITAL FOR REVIEW. THE WHITE LUMEN WAS REVIEWED AND NOTED TO BE EMPTY OF FLUID. NO LIMIT OF AIR ASPIRATED FROM THE LONG LINE CLAMPED BELOW (CATHETER SIDE) OF BIFURCATION, AIR WAS FREELY OBTAINED. THE CATHETER WAS LOOKED AT CLOSELY AND A SPLIT WAS SEEN IN THE CLEAR LUMEN OF THE PROXIMAL LUMEN. PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) CLAMPED ON CATHETER AND REMOVED. THERE WAS A SIX HOUR DELAY REPORTED AS A RESULT OF THIS OCCURRENCE HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 5 FR X 55 CM PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR IV VANOMYCIN VIA INFUSER (24HR)