BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30

    MDR report key: 4092562 · Received August 19, 2014

    Report

    Report Number
    3003898360-2014-00533
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GBZ
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THE TIME OF THIS REPORT. DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE DEFECT REPORTED BY CUSTOMER "METAL SUPPORT TUBE MISSING". A REVIEW OF THE PAST TWO YEARS SHOWS THAT THE ONLY LOT AFFECTED IS 01A1400037. ROOT CAUSE: THE OPERATOR CONFUSED THE 18400 OPERATION, THAT REQUIRES CRIMPING, WITH THE 18305, THAT DOES NOT REQUIRE THIS OPERATION. CORRECTIVE ACTION PERSONNEL WERE NOTIFIED OF THE MISSING SUPPORT TUBE. THE DEVICE DOCUMENTATION WAS REVISED TO ESTABLISH THE NECESSARY CONTROLS TO PREVENT RE-OCCURRENCE OF THIS ISSUE. MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: COMPLAINT ALLEGES THAT THE METAL SUPPORT TUBE WAS MISSING FROM THE CHOLANGIOGRAM CATHETER. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500273 TAUT CHOLANG CATH10/BX 4.5 FR TIP X 30 CHOLANGIOGRAM CATHETER GBZ TELEFLEX 01A1400037

    Patients

    Seq Age Sex Outcome Treatment
    1