BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline

    MDR report key: 14789161 · Received June 23, 2022

    Report

    Report Number
    1417592-2022-00088
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 23, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OHR
    UDI-DI
    10888277862623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON 5/24 THE TIP OF A CATHETER BROKE OFF IN A PATIENT AT THE TIME OF REMOVAL. PER THE FACILITY THE UROLOGIST TOOK THE PATIENT TO THE OPERATING ROOM FOR A CYSTOSCOPY. WHEN THE SCOPE WAS PASSED FOR THE INSPECTION THE FRAGMENT CAME OUT SPONTANEOUSLY AND A NEW CATHETER WAS PLACED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON 5/24 THE TIP OF A CATHETER BROKE OFF IN A PATIENT AT THE TIME OF REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240952 Medline TTL1LYR 16FR10ML 100%SILI UM TRAY OHR MEDLINE INDUSTRIES LP URO170816 10888277862623

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention