BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, ADULT 400 SERIES, 16 FR.

    MDR report key: 1345398 · Received January 9, 2009

    Report

    Report Number
    1221261-2009-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    November 20, 2008
    Report Date
    December 10, 2008
    Manufacturer
    MRI MEDICAL INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RETURNED EVENT SAMPLE WAS FORWARDED TO THE SUPPLIER, (B)(4). A VISUAL INSPECTION OF THE CATHETER SHOWED A TEAR PATTERN IN THE SHAFT SUCH THAT THE CATHETER APPEARED TO BE UNDER TENSILE STRESS PRIOR TO TEARING. A REVIEW OF ALL MANUFACTURING RECORDS DID NOT IDENTIFY ANY RELATED NONCONFORMANCE'S OR OTHER ISSUES RELATED TO THE SHAFT QUALITY. THE QUALITY CONTROL INSPECTION FOR THIS PRODUCT INCLUDES INSPECTION FOR THIS TYPE OF DEFECT WITH THE REQUIREMENT THAT "SHAFT IS SMOOTH AND FREE OF KINKS, CUTS, TEARS, IRREGULAR SURFACE OR CONTAMINATION." ROOT CAUSE: THE MOST LIKELY CAUSE FOR TEARING OF THE SHAFT IS THAT A CUT OR NICK WAS PRESENT IN THE SILICONE. A CUT OR NICK PRESENT IN THE SILICONE MAY HAVE PROPAGATED WITH ADDITIONAL HANDLING AND USE; THIS DEFECT MAY HAVE PROPAGATED TO THE POINT OF FAILURE DUE TO STRAIN WHEN IN USE BY THE PATIENT OR BY THE PATIENT TAMPERING WITH THE DEVICE. WE BELIEVE THIS TO BE AN ISOLATED EVENT LIMITED TO THE SAMPLE RECEIVED AS THERE IS NO TRENDING HISTORY OF DEFECTS OF THIS NATURE FOR THIS PRODUCT. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    USER REPORTS THAT THE NURSE DISCOVERED THE FOLEY CATHETER WAS LEAKING. ON CLOSER INSPECTION, SHE FOUND THAT THE FOLEY HAD SPLIT AND THE INTERNAL TEMPERATURE SENSING WIRE WAS PROTRUDING FROM THE SPLIT. NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER, ADULT 400 SERIES, 16 FR. 78 K -- OD CATHETER, UROLOGICAL, SELF-RETAINED KOD MRI MEDICAL INC. 669005

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR