BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLANT 2-W SILICONE FOLEY, TIEMANN

    MDR report key: 12788881 · Received November 10, 2021

    Report

    Report Number
    8040412-2021-00298
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 29, 2021
    Report Date
    October 29, 2021
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE CONDUCTED. THERE WAS NO COMPLAINT DEVICE RETURNED FOR INVESTIGATION. THEREFORE, NO PHYSICAL ASSESSMENT COULD BE CONDUCTED AND AN INVESTIGATION WAS BASED ON DOCUMENT REVIEW. IN THE ABSENCE OF ANY ACTUAL OR REPRESENTATIVE SAMPLE FOR INVESTIGATION, WE COULD NOT FURTHER INVESTIGATE TO IDENTIFY THE ACTUAL ROOT CAUSE OF THIS REPORTED FAILURE. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    AN INCIDENT INVOLVING A MALE PATIENT HAPPENED IN THE PULMONOLOGY DEPARTMENT ON (B)(6) 2021. WE OBSERVED A LEAK OF THE DEVICE AT THE LEVEL OF THE PATIENT'S PENIS. WE ALSO OBSERVED LEAKS WITH OTHER DEVICES: 1 CATHETER 171305-000140 - LOT NUMBER UNKNOWN, 1 CATHETER 170605-000140 - LOT NUMBER UNKNOWN.

    Description of Event or Problem · 0

    AN INCIDENT INVOLVING A MALE PATIENT HAPPENED IN THE PULMONOLOGY DEPARTMENT ON (B)(6) 2021. WE OBSERVED A LEAK OF THE DEVICE AT THE LEVEL OF THE PATIENT'S PENIS. WE ALSO OBSERVED LEAKS WITH OTHER DEVICES: - 1 CATHETER 171305-000140 - LOT NUMBER UNKNOWN. - 1 CATHETER 170605-000140 - LOT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682922 BRILLANT 2-W SILICONE FOLEY, TIEMANN EZL TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male