BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOS

    MDR report key: 1055244 · Received May 30, 2008

    Report

    Report Number
    6000002-2008-07411
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    EDWARD LIFESCIENCES, PR
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL, DEVICE DISPOSED AT HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANESTHESIOLOGIST WANTED TO TEST HOW DIFFICULT IT WOULD BE TO STRETCH OUT THE GUIDE WIRE. HE OPENED THE KIT AND MANIPULATED THE GUIDE WIRE BY PULLING WITH HIS HANDS, AND IT "EASILY" UNRAVELED. NOT RETURNING DEVICE, DISPOSED AT HOSP. ANOTHER KIT WAS OPENED AND DR COULD NOT MANIPULATE THE GUIDE WIRE. THE GUIDE WIRE STAYED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOS CENTRAL VENOUS CATHETER KIT WITH OLIGON MATERIAL DQO EDWARD LIFESCIENCES, PR SA3720HKI 58460436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other