BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTERIAL LINE KIT: S-L 2 0 GA X 5IN (12 CM

    MDR report key: 1818072 · Received August 20, 2010

    Report

    Report Number
    1036844-2010-00256
    Event Type
    Death
    Date Received
    August 20, 2010
    Date of Event
    June 16, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER MAUDE EVENT REPORT THAT A FEMALE WAS ADMITTED ON (B)(6)2010, WITH LEFT ARM FRACTURE, WHICH OCCURRED DURING A WITNESSED SEIZURE AT HOME. ON (B)(6)2010, SHE HAD A CARDIAC ARREST AND A RIGHT AXILLARY ALINE WAS INSERTED. WHEN THE SPRING WIRE GUIDE (SWG) WAS REMOVED, THE TIP APPEARED FRAYED AND COILED. A CHEST X-RAY (CXR) REVEALED RETAINED CATHETER FRAGMENT IN THE AXILLARY ARTERY. SHE CODED AGAIN AND EXPIRED ON (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL LINE KIT: S-L 2 0 GA X 5IN (12 CM ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. RF0047076

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death