BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN-END FLEXI-TIP URETERAL CATHETER

    MDR report key: 1990935 · Received February 10, 2011

    Report

    Report Number
    1825146-2011-00012
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 9, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    GBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED PACKAGE CONTAINING A USED FLEXI TIP CATHETER WAS RECEIVED. THE RETURNED CATHETER WAS IN THREE SEGMENTS NOTING THE CATHETER WAS SEVERED IN TWO LOCATIONS; THE FIRST SEPARATION LOCATED 11 MM FROM THE CATHETER TIP, BEYOND THE FLEXIBLE BONDED JOINT, NOTING THE NEXT SEPARATION OCCURRED JUST BEFORE THE 5CM INK BAND. POINTS OF SEPARATION WERE NOTED TO HAVE MATING FRACTURES INDICATING ALL PIECES WERE RETURNED. IN VIEWING THE ENDS OF SEPARATION THE EDGES WERE FOUND TO BE ROUNDED INWARD WITH A PINCHED APPEARANCE AND A DARK RESIDUE ON EACH OF THE SEPARATED ENDS. MOST LIKELY THE CATHETER HAS BEEN CUT BY AN INSTRUMENT OF UNDETERMINED ORIGIN.

    Description of Event or Problem · 1

    ONE CATHETER BROKE INTO PIECES INSIDE PT. ADDITIONAL INFO RECEIVED ON 01/17/2011 - CATHETER WAS INTRODUCED INTO THE PTS BLADDER AND FELL APART INTO TWO PIECES. PHYSICIANS WERE ABLE TO EXTRACT THE FRAGMENTS FROM THE PTS BLADDER USING GRASPING FORCEPS. NO ADDITIONAL PROCEDURES WERE NEEDED. NO HARM TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN-END FLEXI-TIP URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY GBL COOK UROLOGICAL INC NA U2011320

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention