BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CATH SET: 20GA X 8CM

    MDR report key: 3842762 · Received May 16, 2014

    Report

    Report Number
    3006425876-2014-00108
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ARROW INTERNATIONAL C.R. A.S.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    SEE MDR 3006425876-2014-00107 FOR THE FIRST REPORT. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH FOLLOWING THE PATIENT'S DISCHARGE FROM HOSPITAL THE PATIENT PRESENTED TO HIS GENERAL PRACTITIONER WITH AN ISCHEMIC RIGHT HAND. THE GENERAL PRACTITIONER REFERRED THE PATIENT TO A VASCULAR SURGEON WHO OPERATED AND REMOVED 2 GUIDE WIRES FROM THE PATIENT'S BRACHIAL ARTERY REGION. THE PATIENT NOTES FOR THE CASE STATE THAT THE PATIENT HAD 2 CATHETERS INSERTED INTO HIS RIGHT RADIAL ARTERY. ONE WAS REMOVED BECAUSE IT WAS NOT "WORKING" SO A SECOND CATHETER WAS PLACED. THE SECOND CATHETER WAS REMOVED WHEN THE PATIENT NO LONGER REQUIRED HEMODYNAMIC MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293019 ARTERIAL CATH SET: 20GA X 8CM ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL C.R. A.S. ZF3052185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention