BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANTEX CENTRAL VENOUS CATHETER W/OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIE

    MDR report key: 1023752 · Received March 24, 2008

    Report

    Report Number
    6000002-2008-06319
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 6, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DISPOSED OF THE HAIR THAT WAS OBSERVED ON THE DEVICE. THE DEVICE AND PACKAGE WILL NOT BE RETURNED; OUR EVALUATION LABORATORY WILL BE UNABLE TO VERIFY REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER OPENED THE VANTEX CENTRAL VENOUS CATHETER AND FOUND A LONG BLACK HAIR STUCK TO THE GUIDE WIRE IN THE STERILE PACKAGE. CUSTOMER DISCARDED THE HAIR BUT KEPT THE CATHETER AND THE PACKAGE. NO PT COMPLICATIONS WERE REPORTED. FOLLOW UP WITH CUSTOMER, INDICATED THAT DEVICE WILL NOT BE RETURNED, HAIR WAS DISPOSED AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTEX CENTRAL VENOUS CATHETER W/OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIE CENTRAL VENOUS CATHETER SET DQO EDWARDS LIFESCIENCES, PR A4820HSI 947AC669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other