BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDPORT IMPLANTED PORT WITH OPEN-ENDED CATHETER

    MDR report key: 1781491 · Received July 28, 2010

    Report

    Report Number
    MW5016842
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 28, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING CHEMOTHERAPY FOR RECTAL CANCER ON (B)(6) 2010. PT NOTED THAT PORT SITE SWELLED DURING INFUSION. NO REDNESS NOTED BUT PT C/O TINGLING SENSATION AT SITE. INFUSION WAS STOPPED AND A PERIPHERAL IV LINE WAS STARTED TO COMPLETE TREATMENT. PT WAS SCHEDULED FOR AND UNDERWENT A PORT EVALUATION UNDER FLUOROSCOPY ON (B)(6) 2010. FINDINGS WERE AS FOLLOWS: "CONTRAST IS INJECTED INTO THE PORT-A-CATH WHICH IS OVER THE RIGHT SIDE OF THE CHEST ENTERING INTO THE RIGHT SUBCLAVIAN VEIN WITH TIP IN THE SUPERIOR VENA CAVA. THE MAJORITY OF THE CONTRAST EMPTIES INTO THE SUPERIOR VENA CAVA HOWEVER, THERE IS LEAKAGE OF CONTRAST WHICH OCCURS FROM THE CATHETER AT THE THORACIC OUTLET BETWEEN THE FIRST RIB AND THE CLAVICLE. THERE IS AN ABNORMALITY OF THE RIGHT-SIDED PORT-A-CATH WITH A SMALL BREAK IN THE CATHETER AT THE THORACIC OUTLET WHICH IS ALLOWING FOR CONTRAST TO EXTRAVASATE INTO THE SOFT TISSUES." PT HAD SURGERY ON (B)(6) 2010 FOR REMOVAL OF THE LEAKING PORT AND PLACEMENT OF A LEFT-SIDED PORT-A-CATH. UPON REMOVAL OF THE PORT, THE CATHETER WAS NOTED TO HAVE A 1/4 INCH BILATERAL SPLIT AT APPROX 12CM. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: RECTAL CANCER. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT IMPLANTED PORT WITH OPEN-ENDED CATHETER PORT-A-CATH LJT C.R. BARD, INC. 0605320 RETG0611

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability