BEUDAMED
    FDA Adverse Event Injury Summary report: N

    16F LATEX FOLEY CATHETER

    MDR report key: 3876479 · Received June 9, 2014

    Report

    Report Number
    1417592-2014-00058
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAD BEEN INSERTED DURING SURGERY AND SALINE AND METHYLENE BLUE HAD BEEN INSTILLED INTO THE PATIENT'S BLADDER. THE CATHETER STOPPED DRAINING AND THE CLINICIAN WAS UNABLE TO DEFLATE THE BALLOON. THEY CUT THE CATHETER AND IT BEGAN TO DRAIN. A NEW CATHETER WAS INSERTED. NO PATIENT INJURY RESULTED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CATHETER WOULD NOT DRAIN, REQUIRING ANOTHER CATHETER TO BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334396 16F LATEX FOLEY CATHETER NONE NWR MEDLINE INDUSTRIES, INC. 14MB4215

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention