BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FOLEY CATHETER, 14F

    MDR report key: 4008327 · Received July 11, 2014

    Report

    Report Number
    1417592-2014-00068
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSERTION OF THE FOLEY CATHETER, THE BALLOON WOULD NOT INFLATE. A NEW CATHETER WAS INSERTED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY RESULTED. THE SAMPLE WAS RETURNED AND EVALUATED. THE BALLOON WAS TESTED. IT INFLATED NORMALLY AND DEFLATED PASSIVELY AS INTENDED. HOWEVER, AFTER APPROXIMATELY 10 SECONDS, A DROP OF FLUID WAS NOTED TO LEAK FROM THE INFLATION PORT. THE INFLATION VALVE DID NOT FULLY CLOSE AFTER THE SYRINGE WAS REMOVED FROM THE PORT. THIS IS THE FIRST REPORTED INCIDENT OF THIS NATURE FOR THIS DEVICE. A ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT INFLATE AND A NEW CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408139 SILICONE FOLEY CATHETER, 14F NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other