BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1190578 · Received October 2, 2008

    Report

    Report Number
    3006260740-2008-00143
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 30, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    DETACHMENT OR BREAKAGE OF THE HOOPED SNARE. WHEN THE DOCTOR USED THE GRASPING SNARE TO REMOVE THE CATHETER, THE HOOPED SNARE BROKE OR DETACHED PARTIALLY FROM ITS BASE (THE DOCTOR IS UNCERTAIN) AND THE CATHETER FELL INTO THE PATIENT'S STOMACH. THE FALLEN CATHETER WAS REMOVED WITH ANOTHER SNARE. THE DOCTOR COMMENTED THAT THE GRASPING SNARE WAS MADE FOR GRASPING THE INSERTION WIRE ONLY, SO HE SHOULD NOT HAVE USED IT FOR REMOVING THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) PEGS KNT C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention