BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, ADULT 400 SERIES, 16 FR.

    MDR report key: 1325728 · Received December 18, 2008

    Report

    Report Number
    1221261-2008-00039
    Event Type
    Malfunction
    Date Received
    December 18, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MRI MEDICAL INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - OTHER: INVESTIGATION: THE RETURNED EVENT SAMPLE WAS FORWARDED TO THE SUPPLIER, MRI MEDICAL. 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 NON CONFORMANCES 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 BEEN PROPOGATED WITH ADDITIONAL HANDLING AND USE; THIS DEFECT MAY HAVE PROPOGATED 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 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 A REMNANT PART OF THE TUBING BROKE OFF AND HAD TO BE SURGICALLY REMOVED FROM THE PATIENT. THE CATHETER HAD BEEN IN PLACE FOR ONE WEEK. 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. 687302

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention