BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOSTAR CENTRAL VENOUS CATHETER

    MDR report key: 1215640 · Received October 20, 2008

    Report

    Report Number
    1056436-2006-00083
    Event Type
    Other
    Date Received
    October 20, 2008
    Date of Event
    November 29, 2006
    Report Date
    October 15, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT, "CUFF SLIDING UP AND DOWN", WAS CONFIRMED. THE CAUSE OF THE CUFF SLING UP AND DOWN MAY HAVE BEEN DUE TO AN INADEQUATE AMOUNT OF ADHESIVE APPLIED TO THE CUFF DURING THE MANUFACTURING PROCESS. NO MANUFACTURING VARIANCES WERE OBSERVED RELATED TO THIS EVENT DURING THE DEVICE HISTORY RECORD REVIEW. A CORRECTIVE ACTION WAS IMPLEMENTED TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    CUFF FAILED...CUFF SLIDING UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOSTAR CENTRAL VENOUS CATHETER CHRONIC CVC CATHETER DQO ANGIODYNAMICS, INC. NA 28207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other