BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN-END FLEXI-TIP URETERAL CATHETER

    MDR report key: 3980968 · Received July 22, 2014

    Report

    Report Number
    1820334-2014-00338
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 27, 2014
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    GBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON WAS PRESENTED WITH A 5FR ACCESS LUMEN INTO THE PEDIATRIC SCOPE. THE CATHETER WAS USED SEEMINGLY FINE WITHOUT DIFFICULTY; HOWEVER, UPON PULLING THE CATHETER BACK OUT OF THE SCOPE, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. THE PART OF THE CATHETER THAT WAS PULLED OUT LOOKED LIKE IT WAS CRACKED. THE SURGEON WENT BACK INSIDE THE PATIENT AND REMOVED THE "BROKE OFF" PORTION OF THE CATHETER WITHOUT DIFFICULTY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE SURGEON WENT BACK INSIDE THE PATIENT AND REMOVED THE "BROKE OFF" PORTION OF THE CATHETER WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429408 OPEN-END FLEXI-TIP URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY GBL COOK UROLOGICAL INC NA U2478144

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention