BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2201461 · Received August 3, 2011

    Report

    Report Number
    9680794-2011-00053
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    March 28, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE SURGICAL CENTER FOR A LAPAROTOMY FOR ABSCESS AND NEPHROSTOMY. THE CLINICIAN WAS UNABLE TO DO A SALINE INFUSION AS THE LUMEN OF THE CATHETER PLACED IN THE PATIENT'S INTERNAL JUGULAR WAS OBSTRUCTED. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITHOUT ISSUE. THERE WAS A DELAY, HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. CF0061225

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR