BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER, FOLEY, SIL-ELASTOMER

    MDR report key: 972018 · Received December 13, 2007

    Report

    Report Number
    1417592-2007-00054
    Event Type
    Other
    Date Received
    December 13, 2007
    Report Date
    December 12, 2007
    Manufacturer
    MEDLINE INDUSTIRES, INC
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE AND PACKAGING CONFIRMED THAT THIS CATHETER WAS MANUFACTURED NINE YRS AGO. THE END USER FACILITY STATED, IT HAD BEEN ON THEIR SHELVES FOR A LONG TIME. IT WAS REPORTED THE CATHETER WAS INSERTED WITHOUT DIFFICULTY. UPON REMOVAL, IT WAS NOTED THAT IT HAD BROKEN. THE TIP WAS REMOVED WITH THE AID OF A HEMOSTAT. THERE WAS NO SERIOUS INJURY OR NEGATIVE CONSEQUENCE FOR THE PT. THE END OF THE CATHETER HAD SEPARATED INTO 2 PIECES. SAMPLE WAS FORWARDED TO MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A CATHETER HAD BEEN INSERTED PRIOR TO A SURGICAL PROCEDURE. UPON COMPLETION OF THE PROCEDURE, THE BALLOON WAS DEFLATED AND THE CATHETER WAS REMOVED. UPON REMOVAL, IT WAS DISCOVERED THAT THE CATHETER HAD BROKEN, LEAVING THE TIP IN THE PT. THEY TOOK A HEMOSTAT AND REMOVED THE PIECE WITHOUT INCIDENT. THERE WAS NO SERIOUS INJURY OR NEGATIVE CONSEQUENCE TO THE PT. THE CATHETER WAS DETERMINED TO BE NINE YRS OLD. THE END USER FACILITY STATED, IT HAD BEEN ON THEIR SHELVES FOR A LONG TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, FOLEY, SIL-ELASTOMER NONE KOD MEDLINE INDUSTIRES, INC DYND11710 98E03R

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention