BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 12365158 · Received August 25, 2021

    Report

    Report Number
    1417592-2021-00162
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 1, 2021
    Report Date
    December 29, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OHR
    UDI-DI
    10889942687145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE RETURNED FOR EVALUATION ON 8/23/3021. THE SAMPLE WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORTED ISSUE OF A DEFLATED FOLEY CATHETER BALLOON WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RECEIVED SAMPLE. BASED ON THE CONDITION OF THE SAMPLE, THE SUSPECTED ROOT CAUSE IS A PATIENT SPECIFIC CONDITION CONTRIBUTING TOWARDS THE PUNCTURE/BURST OF THE BALLOON. NO ADDITIONAL INFORMATION IS AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT, APPROXIMATELY FIVE (5) MINUTES AFTER INSERTION, THE URINARY CATHETER BALLOON BURST. THE URINARY CATHETER CAME OUT OF THE PATIENT AND A NEW URINARY CATHETER WAS INSERTED WITHOUT FURTHER REPORTED INCIDENT. WHEN THE URINARY CATHETER WAS REPORTEDLY INSPECTED BY THE PATIENT'S NURSE, THE NURSE NOTED A TEAR. THERE WAS NO ADVERSE IMPACT OR SERIOUS INJURY RELATED TO THE INCIDENT. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO INSERT A NEW URINARY CATHETER, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URINARY CATHETER BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266056 MEDLINE TTLVENT 16FR10ML 100%SIL UM TR OHR MEDLINE INDUSTRIES INC. URO180816 592191203 10889942687145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention