BEUDAMED
    FDA Adverse Event Summary report: N

    MAHURKAR CENTRAL VAS CATH

    MDR report key: 3082640 · Received April 24, 2013

    Report

    Report Number
    3082640
    Date Received
    April 24, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS AN (B)(6) MALE WITH A PRIMARY DIAGNOSIS OF OPTIC NEURITIS. THE PT WAS UNDERGOING HIS THIRD PHERESIS TREATMENT IN THE APHERESIS CLINIC ON (B)(6) 2013. THE IJ CATHETER WAS ACCESSED WITH EXCELLENT BLOOD RETURN AND FLOW RATES. SEVERAL MINUTES INTO THE PROCEDURE, THE PT STATED THAT HE FELT FLUID RUNNING DOWN HIS BACK. THE CATHETER WAS INSPECTED. IT WAS DISCOVERED THAT THE FLEXIBLE PORTION OF THE CATHETER HAD SEPARATED FROM THE HUB. THE HUB WAS SUTURED TO THE PT'S NECK. THE CATHETER WAS MOVING IN AND OUT OF THE PT'S NECK WITH HIS RESPIRATIONS AND THERE WAS SIGNIFICANT BLEEDING FROM THE INSERTION SITE. THE CATHETER WAS STABILIZED BY HAND AND HELD IN POSITION TO PREVENT IT FROM MIGRATING FURTHER INTO THE VESSEL. A PHYSICIAN REMOVED THE CATHETER AND ORDERED NS FLUID BOLUS TO BE GIVEN. FLUIDS WERE RUN THROUGH A 22G PIV IN THE RIGHT HAND. PRESSURE WAS HELD "X" 15 MINUTES AT CATHETER REMOVAL SITE. AN 18G PIV WAS INSERTED IN THE PT'S RIGHT MEDIAL AC FOR ANY ADDITIONAL FLUID BOLUSES OR MEDICATIONS. THE PT CONTINUED TO COUGH AND COMPLAINED OF PAIN IN HIS NECK AREA AS WELL AS SHORTNESS OF BREATH. THE PT BEGAN TO STABILIZE AFTER THE CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177204 MAHURKAR CENTRAL VAS CATH CENTRAL VENOUS CATHETER MPB COVIDIEN 8888136165 208208X

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention