BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KATEX FOLEY CATHETER TRAY, 16F

    MDR report key: 3621483 · Received January 30, 2014

    Report

    Report Number
    1417592-2014-00008
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 24, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS INSERTED IN THE OPERATING ROOM PRIOR TO A SURGICAL PROCEDURE. LATER THAT DAY, THE CLINICIAN WAS UNSUCCESSFUL IN DEFLATING THE BALLOON IN ORDER TO REMOVE THE CATHETER. SHE CUT THE PIGTAIL ON THE INFLATION PORT AND OBSERVED SOME DROPS OF FLUID BUT FULL DEFLATION WAS NOT ACHIEVED. THE PHYSICIAN ATTEMPTED TO RUPTURE THE BALLOON BY INSERTING A NEEDLE BUT WAS UNSUCCESSFUL. DURING THE NIGHT, WHEN THE PATIENT GOT UP, THE CATHETER FELL OUT ON ITS OWN. NO ADD'L INTERVENTION WAS NECESSARY. THE CATHETER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED A DEFLATED BALLOON AND A SEVERED INFLATION VALVE. THE INFLATION VALVE WAS NOT RETURNED TO US. THE CATHETER BALLOON WAS INFLATED THROUGH THE INFLATION LUMEN WITH WATER. THE BALLOON INFLATED AND DEFLATED AS INTENDED. THE REPORTED ISSUE COULD NOT BE DUPLICATED WITH THE RETURNED SAMPLE. A ROOT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE CLINICIAN ATTEMPTED TO REMOVE THE CATHETER FOLLOWING A SURGICAL PROCEDURE. THE BALLOON WOULD NOT DEFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66231 KATEX FOLEY CATHETER TRAY, 16F NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention