BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SIMPLY LATEX 2 LAYER SILICONE-ELASTOMER FOLEY CATHETER TRAYS

    MDR report key: 19996161 · Received August 14, 2024

    Report

    Report Number
    MW5158479
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    August 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INDWELLING URINARY CATHETER PLACED IN 87 Y/O M PATIENT. UPON ENTRANCE INTO THE BLADDER, URINE STREAM NOTED TO BE SPRAYING OUT OF A PREVIOUSLY NOT VISIBLE PINHOLE IN THE CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350680 MEDLINE SIMPLY LATEX 2 LAYER SILICONE-ELASTOMER FOLEY CATHETER TRAYS CATHETER, RETENTION TYPE, BALLOON EZL MEDLINE INDUSTRIES, LP - NORTHFIELD 24CBQ086

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Other