BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER, 16F

    MDR report key: 3952022 · Received July 15, 2014

    Report

    Report Number
    1417592-2014-00069
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO REMOVING THE CATHETER, THE BALLOON WOULD NOT DEFLATE. THE INFLATION PORT WAS CUT BY THE CLINICIAN AND THE BALLOON DID NOT PASSIVELY DEFLATE. THE CATHETER WAS THEN CUT CLOSER TO WHERE IT EXITED THE PT. WHEN THE BALLOON STILL DID NOT DEFLATE, THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY AND THE BALLOON WAS MANUALLY RUPTURED WITH A NEEDLE. THE SAMPLE WAS NOT RELEASED FOR EVAL. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE AND THE CATHETER WAS REMOVED IN INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412941 LATEX FOLEY CATHETER, 16F NWR MEDLINE INDUSTRIES, INC. RRIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention