BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CANNULA

    MDR report key: 3010958 · Received March 15, 2013

    Report

    Report Number
    2243072-2013-00008
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    June 29, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, UNDER A PROCEDURE IN GYNECOLOGY WARD THE PT HAD AN ARTERIAL CANNULA INSERTED. THEY DISCONTINUED IT A FEW DAYS LATER. IN (B)(6) 2012, THE PT EXPERIENCED A LUMP, PAIN AND DISCOLORATION IN THE AREA AROUND THE ARTERIAL RADIALIS. AN MRI AND ULTRASOUND WERE PERFORMED AND AN OBJECT IN THE ARTERIAL RADIALIS WAS IDENTIFIED. ON (B)(6) 2012, THE OBJECT ALLEGED TO BE A BROKEN PIECE OF CATHETER WAS REMOVED AND THE LUMP, PAIN AND DISCOLORATION RESOLVED. ADDITIONAL INFO RECEIVED FROM THE CUSTOMER ON (B)(6) 2013, WHO STATED THAT THE CATHETER WAS PROBABLY HARMED UNDER INSERTION WHEN PULLING THE CANNULA BACK AND FORTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110302 ARTERIAL CANNULA 20G X 45MM ARTERIAL CANNULA DWF BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention