BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTG T/L CATH S/A, 15CM

    MDR report key: 348053 · Received August 15, 2001

    Report

    Report Number
    1720496-2001-00404
    Event Type
    Malfunction
    Date Received
    August 15, 2001
    Date of Event
    June 14, 2000
    Report Date
    June 29, 2000
    Manufacturer
    3600-C.R.BARD ACCESS SYSTEMS PRODUCTS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER LEAKED DURING INSERTION. REMOVED AND REPLACED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37291 OTG T/L CATH S/A, 15CM LONG TERM INTRAVASCULAR CATHETER FOZ 3600-C.R.BARD ACCESS SYSTEMS PRODUCTS 7735157 36LJ0006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other