BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II IMPLANTED VENOUS ACCESS SYSTEM

    MDR report key: 3883930 · Received June 12, 2014

    Report

    Report Number
    2183502-2014-00395
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    FROM CLINICAL TRIAL STUDY ORGANIZER: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PATIENT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG ON (B)(6) 2013 AND PATIENT BEGAN TRIAL (B)(6) 2013. ACCORDING TO REPORTER, PATIENT WAS ADMITTED TO HOSPITAL (B)(6) 2014 FOR CATHETER BREAKAGE. THE DOSE OF ARYLSULFATASE WAS NOT GIVEN TO PATIENT (B)(6) 2014 AND DOSE WAS PROVIDED TO PATIENT VIA LUMBAR PUNCTURE ON (B)(6) 2014. IMPLANTED VENOUS ACCESS SYSTEM WAS REPLACED WITH DIFFERENT BRAND SYSTEM ON (B)(6) 2014 AND PATIENT WAS DISCHARGED FROM HOSPITAL. NO PERMANENT ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348398 PORT-A-CATH II IMPLANTED VENOUS ACCESS SYSTEM CATHETER, PERCUTANEOUS, LONG TERM FOZ SMITHS MEDICAL 21-1500 2059573

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other| R