BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDPORT (C.R. BARD INC.)

    MDR report key: 146353 · Received December 9, 1997

    Report

    Report Number
    146353
    Event Type
    Malfunction
    Date Received
    December 9, 1997
    Date of Event
    October 9, 1997
    Report Date
    November 10, 1997
    Manufacturer
    BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PORT A CATH INSERTED 10/1/97. UNDER FLUOROSCOPY EXCELLENT FLOW BOTH PORTS. USED WITHOUT INCIDENT WHILE STILL HOSPITALIZED 10/4/97. RETURNED 10/9/97 AS AN OUTPATIENT. ABLE TO FLUSH, BUT UNABLE TO DRAW BACK FOR BLOOD RETURN. CONTRAST STUDY COMPLETED. TIP WHICH HAD BEEN POINTING INFERIORLY DOWN THE SUPERIOR VENA CAVA WAS NOW POINTING MEDIALLY. CONTRAST INJECTED, MOST FLOWED DOWN SUPERIOR VENA CAVA, BUT A CERTAIN AMOUNT OF CONTRAST FLOWED BACK ALONG THE OUTSIDE OF THE PORT A CATH TOWARDS THE PORT ITSELF, INDICATING A PROBABLE LEAK. REMOVED 10/17/97 AND NEW DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDPORT (C.R. BARD INC.) Implant OPEN-ENDED TWIN PORT PORT A CATH LJT BARD 0607100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 11/4/97 - IV DOBUTAMINE THERAPY