BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER, 16FR

    MDR report key: 4992210 · Received August 8, 2015

    Report

    Report Number
    1417592-2015-00068
    Event Type
    Injury
    Date Received
    August 8, 2015
    Date of Event
    June 12, 2015
    Report Date
    August 6, 2015
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AN RN ATTEMPTED TO REMOVE THE FOLEY CATHETER AND THE BALLOON WOULD NOT DEFLATE. SHE WITHDREW APPROXIMATELY 2 ML OF SALINE FROM THE BALLOON AND THE TUBING COLLAPSED PREVENTING ANY MORE SALINE TO WITHDRAWN. THE RN CUT THE TUBING BUT NO SALINE CAME OUT. A UROLOGIST CAME IN AND ATTEMPTED TO BURST THE BALLOON WITH A GUIDEWIRE WITH NO SUCCESS. THE PATIENT WAS TAKEN TO ULTRASOUND WHERE THE CATHETER WAS SUCCESSFULLY REMOVED. THE INTERVENTION TAKEN IN ULTRASOUND TO REMOVE THE CATHETER IS NOT KNOWN. IT IS NOT KNOWN IF THE CATHETER WAS REPLACED. NO OTHER DETAILS WERE PROVIDED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521183 FOLEY CATHETER, 16FR NWR MEDLINE INDUSTRIES, INC. 15AB5942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other