BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH

    MDR report key: 1160925 · Received September 12, 2008

    Report

    Report Number
    MW5008300
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 12, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A PORT-A-CATH REMOVED. UPON REMOVAL, MD NOTED CATHETER WAS DETACHED FROM PORT. PT WAS SENT TO ABBOTT. FOR INTERVENTIONAL RADIOLOGY FOR CATHETER REMOVAL. PORT HAD BE IN PLACE SINCE 2007. DATES OF USE: 2007 - 2008 15 MONTHS. DIAGNOSIS OR REASON FOR USE: VENOUS ACCESS FOR CHEMOTHERAPY FOR TREATMENT OF BREAST. THE ONLY OTHER THING I WOULD LIKE YOU TO BE AWARE OF THAT THIS IS THE SECOND TIME WE HAVE REPORTED THIS TYPE OF INCIDENT WITH A PORT-A-CATH THIS YR. THE OTHER REPORT WAS SENT TO THE FDA ON MARCH 18, 2008. THE LOT NUMBER OF THE FIRST PORT-A-CATH WAS DIFFERENT THAN THIS ONE. PREVIOUS REPORT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH VENOUS ACCESS DEVICE LJT SMITHS MEDICAL M45780

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability