BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 16F

    MDR report key: 3854878 · Received May 23, 2014

    Report

    Report Number
    1417592-2014-00052
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 18, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO REMOVAL OF THE CATHETER, THE CLINICIAN ATTACHED THE SYRINGE TO THE INFLATION PIGTAIL AND REMOVED FLUID FROM THE BALLOON. AS SHE PULLED ON THE CATHETER, SHE FELT SOME RESISTANCE. SHE CONTINUED TO PULL, REMOVED THE CATHETER AND NOTED THE BALLOON WAS NOT FULLY DEFLATED. IT IS NOT KNOWN WHY THE CLINICIAN DID NOT IDENTIFY A DISCREPANCY BETWEEN THE VOLUME REMOVED FROM THE BALLOON COMPARED TO THE INITIAL VOLUME INSTILLED. A SMALL AMOUNT OF BLEEDING WAS NOTED BUT THE FACILITY REPORTED THAT NO SERIOUS INJURY RESULTED AND MEDICAL INTERVENTION WAS NOT INDICATED. THE CATHETER WAS BEING DISCONTINUED AND THERE WAS NO NEED FOR IT TO BE REPLACED. THE SAMPLE WAS RETURNED AND EVALUATED. THE CATHETER BALLOON WAS FOUND TO HAVE 1-2ML OF RETAINED FLUID IN IT. THE BALLOON INFLATION LUMEN WAS COLLAPSED NEAR THE IRRIGATION EYE WITHIN THE BALLOON. A POSSIBLE ROOT CAUSE FOR THE COLLAPSED LUMEN MAY HAVE BEEN THE INCREASED VACUUM PRESSURE CREATED BY THE PULLBACK ON THE SYRINGE.

    Description of Event or Problem · 1

    THE CATHETER BALLOON WAS NOT FULLY DEFLATED PRIOR TO REMOVAL FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309113 LATEX FOLEY CATHETER, 16F NWR MEDLINE INDUSTRIES, INC. QXIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other