BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN (1

    MDR report key: 2013788 · Received February 4, 2011

    Report

    Report Number
    2242445-2011-00018
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 24, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL VENOUS CATHETER (CVC) WAS BEING PLACED FOR A (B)(6) FEMALE PATIENT. THE CATHETER WAS BEING PLACED INTO THE PATIENTS' SUBCLAVIAN VEIN. DURING REMOVAL OF THE SPRING WIRE GUIDE (SWG) IT BECAME UNRAVELED, BUT WAS REMOVED COMPLETELY INTACT. THEY WERE ABLE TO KEEP THE CATHETER IN PLACE THEREFORE, NO OTHER KIT WAS OPENED. THERE WAS NO DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME WAS AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6IN (1 ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR