BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 3-L 7FR X 20 CM AGB

    MDR report key: 4579993 · Received March 4, 2015

    Report

    Report Number
    1036844-2015-00071
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 19, 2015
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE RIGHT SUBCLAVIAN IN THE EMERGENCY DEPARTMENT. DURING INSERTION THE PHYSICIAN USED ULTRASOUND, GUIDED THE NEEDLE AND OBTAINED POSITIVE BLOOD RETURN OF APPROXIMATELY 5-6CC. HE HELD THE NEEDLE IN PLACE WHILE REMOVING THE SYRINGE. AT WHICH TIME, HE PULLED THE ARROW ADVANCER GUIDE WIRE BACK INTO THE BLUE INTRODUCER ATTACHMENT AND PLACED THE ADVANCER TIP TO THE HUB OF THE INTRODUCER NEEDLE. HE BEGAN ADVANCING THE WIRE AND AFTER TWO THUMB SLIDES THERE WAS SOME HESITATION BUT HE PUSHED THE WIRE AND FELT LIKE THE WIRE WENT IN. HE REMOVED THE NEEDLE, NICKED FOR THE DILATOR AND THREADED THE CATHETER OVER THE GUIDE WIRE WITHOUT RESISTANCE. THE GUIDE WIRE CAME OUT THE DISTAL EXTENSION LINE PROPERLY. THE PHYSICIAN PULLED THE GUIDE WIRE BACK ABOUT 3-4 INCHES AND CAME TO A HALT. THE PHYSICIAN STATES "IT'S CAUGHT" YET PULLED STEADY, NOT HARD, AND THE GUIDE WIRE STRETCHED SLIGHTLY. HE MOVED HIS HAND DOWN NEXT TO THE DISTAL HUB, GRASPED THE WIRE AND PULLED STEADY. THE GUIDE WIRE SLIGHTLY STRETCHED AGAIN AND THE RELEASED AND REMOVED SMOOTHLY. THE PHYSICIAN FINISHED SUTURING THE CATHETER IN PLACE AND CHECKED FOR BLOOD RETURN. THERE WAS NO BLOOD RETURN FROM THE DISTAL LUMEN YET THERE WAS GOOD RETURN FROM THE MEDICAL AND PROXIMAL LUMENS. THE PHYSICIAN TOLD THE NURSE NOT TO USE THE LINE AND ORDERED A CHEST X-RAY. THE CHEST X-RAY SHOWED THE CATHETER HAD LOOPED AND COILED IN THE VEIN. THE PHYSICIAN TRIED TO MANIPULATE THE CATHETER TO SEE IF IT WOULD UNCOIL YET SECOND CHEST X-RAY SHOWED NO IMPROVEMENT. AS A RESULT, THE PHYSICIAN REMOVED THE CATHETER WITHOUT PROBLEMS AND SENT THE PATIENT TO THE INTENSIVE CARE UNIT WITHOUT ANOTHER ATTEMPT. THE PATIENT HAD A 20GA PERIPHERAL LINE INSERTED AND WAS TRANSPORTED TO ICU. ANOTHER PHYSICIAN IN ICU TOLD AN RN THAT THE PATIENT HAD TOO MUCH TISSUE AND CONSULTED WITH ANESTHESIA. ANESTHESIA PLACED A DUAL 14GA IN THE RIGHT INTERNAL JUGULAR WITHOUT COMPLICATIONS. THE PATIENT REMAINED IN THE ICU. THERE WAS A DELAY IN TREATMENT. HOWEVER, NO PATIENT HARM, COMPLICATION OR DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151450 PI CVC KIT: 3-L 7FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F14L0293

    Patients

    Seq Age Sex Outcome Treatment
    1