BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL INC. MRI SUBCUTANEOUS PORT

    MDR report key: 17079 · Received September 14, 1994

    Report

    Report Number
    17079
    Event Type
    Injury
    Date Received
    September 14, 1994
    Date of Event
    June 1, 1994
    Report Date
    August 12, 1994
    Manufacturer
    DAVOL, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DIAGNOSED WITH LEUKEMIA HAD A SUBCUTANEOUS PORT INSERTED ON 5/6/94 FOR CHEMOTHERAPY. READMITTED ON 7/6/94 DUE TO RELAPSE OF LEUKEMIA. WHEN ATTEMPT WAS MADE TO FLUSH CATHETER, IT COULD NOT BE DONE. X-RAY SHOWED THAT END OF CATHETER WAS SHEARED OFF AND LODGED IN THE SUPERIOR VENA CAVA. ON 7/8/94 VIA CARDIAC CATHETERIZATION, THE CATHETER TIP WAS REMOVED. ON 7/11 THE REMAINDER OF THE EXTERNAL CATHETER WAS REMOVED AND A NEW TRIPLE LUMEN CATHETER WAS INSERTED. POST-OPERATIVELY, PT HAD CHEMO AND BECAME FEBRILE. HE EVENTUALLY STABILIZED AND WAS DISCHARGED 8/5/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL INC. MRI SUBCUTANEOUS PORT Implant PORT-A-CATH LJT DAVOL, INC. 0602680 36BE7344

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention