BEUDAMED
    FDA Adverse Event Other Summary report: N

    CATHETER, FOLEY, 16FR 5CC, SILI

    MDR report key: 1671807 · Received March 29, 2010

    Report

    Report Number
    1417592-2010-00015
    Event Type
    Other
    Date Received
    March 29, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS INSERTED INTO A PATIENT IN THE ER IN AN EFFORT TO DECOMPRESS HIS BLADDER. AFTER A SHORT PERIOD OF TIME, IT WAS REMOVED AND FOUND IT TO BE FRACTURED. A PIECE WAS RETAINED IN THE PATIENT. THE PIECE WAS REMOVED VIA A CYSTO PROCEDURE. THERE WERE NO OTHER COMPLICATIONS RESULTING FROM THIS INCIDENT. IT WAS REPORTED THAT THE INSIDE OF THE CATHETER LOOKED DRY AND CRACKED. THE FACILITY DID NOT KNOW HOW LONG THE CATHETER HAD BEEN IN THEIR STOCK AND NOTED IT WAS STORED FOLDED IN THEIR PIXIS MACHINE. THE FACILITY WILL NOT RELEASE THE CATHETER FOR EVALUATION. BASED ON THE REPORTED LOT NUMBER, IT WAS DETERMINED THE CATHETER WAS MANUFACTURED IN 2004. IT IS NOT KNOWN HOW OR WHERE THE CATHETER WAS STORED. THE LABELING STATES THAT THE PRODUCT SHOULD BE STORED AWAY FROM DIRECT EXPOSURE TO LIGHT AT ROOM TEMPERATURE. IF THE PRODUCT WAS STORED OUTSIDE OF RECOMMENDED PARAMETERS, IT COULD HAVE AFFECTED ITS INTEGRITY. WE HAVE NO SAMPLE TO EVALUATE AND A ROOT CAUSE HAS NOT BEEN DETERMINED. HOWEVER, DUE TO THE REPORTED INCIDENT, THIS MDR IS BEING FILED.

    Description of Event or Problem · 1

    A CATHETER BROKE OFF INSIDE A PATIENT AND HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, FOLEY, 16FR 5CC, SILI NONE KOD MEDLINE INDUSTRIES, INC. DYND11756 2004-1-05R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention