BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 16343 · Received January 25, 1994

    Report

    Report Number
    16343
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    November 1, 1993
    Report Date
    November 24, 1993
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MDV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PORT A CATH INSERTED 10/13/93. ON 10/23/93, AFTER CHEMOTHERAPY INFUSED, PORTACATH CHECKED FOR BLOOD RETURN, HAD GOOD BLOOD RETURN. PORTACATH WS FLUSHED. AFTER NEEDLE REMOVED, ORANGE FLUID SEEPED OUT OF NEEDLE SITE. PT. WAS TREATED AS EXTRAVASATION.ON 11/1/93 PT. HAD SURGERY. PORTACATH WAS ACCESSED AND IT COULD BE SEEN THAT HEPARINIZED SALINE WAS FLOWING OUT OF THE CATHETER AT THE POINT OF CONNECTION. ALSO NOTED THAT THE ACTUAL SLEEVE OF THE CATHETER HAD COMPLETELY FRACTURED AND WAS LYING FREE, A PORTION OF IT WAS LYING COMPLETELY FREE AROUND THE SILASTIC TUBING. PORTACATH WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD Implant MRI HARD BASE IMPLANTED PORT MDV BARD ACCESS SYSTEMS UNKNOWN 36JD5461

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention