BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL ARTERY CATHETER

    MDR report key: 3896240 · Received June 20, 2014

    Report

    Report Number
    MW5036817
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ARROW
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ARTERIAL LINE WAS PLACED ON (B)(6) 2014 INTO ARTERIAL ARTERY. ARTERIAL LINE LEAKING AND NOT READING CORRECTLY. WHEN NURSE WENT TO DC LINE NOTED BLOOD LEAKING FROM INSERTION SITE. ARTERIAL LINE REMOVED AND NOTED TO FULL 1 1/2" CATHETER WAS NOT INTACT. X-RAY TAKEN AND NOTES: 3.5 CM LINEAR FOREIGN BODY IN THE LATERAL VOLAR ASPECT OF THE LEFT WRIST, CONSISTENT WITH RETAINED CATHETER FRAGMENT. CATHETER NOT REMOVED AS OF YET DUE TO PATIENT CONDITION. DATES OF USE: (B)(6) 2014 - (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364061 RADIAL ARTERY CATHETER RADIAL ARTERIAL CATHETER DQY ARROW HF 04020-1-S 23F14B0368

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other