BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL

    MDR report key: 12788909 · Received November 10, 2021

    Report

    Report Number
    8040412-2021-00299
    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.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). AN ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT LEAK WAS OBSERVED AT THE LEVEL OF PATIENT'S PENIS. HOWEVER, VISUAL INSPECTION CONDUCTED ON THE RETURNED SAMPLE FOUND THAT THE URINE BAG WAS NOT MANUFACTURED BY TELEFLEX MEDICAL. THUS, FURTHER EVALUATION ON THE URINE BAG COULD NOT BE CONDUCTED AS IT IS NOT PART OF OUR PRODUCT. INVESTIGATION WAS INITIATED BY ALLOWING RED COLOR WATER THROUGH THE DRAINAGE CHANNEL OF THE CATHETER TO OBSERVE ANY POINT OF LEAK. HOWEVER, NO LEAK WAS OBSERVED AND THE CATHETER ABLE TO FUNCTION AS PER INTENDED. FURTHER ON THE INVESTIGATION, THE CATHETER BALLOON WAS ALSO INFLATED WITH 10ML OF WATER TO OBSERVE ANY SIGN OF LEAK THROUGH THE INFLATION CHANNEL. AGAIN, NO LEAK WAS DETECTED AND VERIFIED THAT THERE WAS NO LEAK ISSUE FOUND WITHIN THE CATHETER. BESIDES THAT, ALTHOUGH THE URINE BAG WAS NOT PART OF TELEFLEX PRODUCT, THE COMPATIBILITY OF THE URINE BAG AND THE CATHETER HAD ALSO BEEN TESTED. UPON ALLOWING RED COLOR WATER THROUGH THE CATHETER, THERE WAS NO LEAK FOUND BETWEEN THE FUNNEL AND THE CONNECTOR OF THE URINE BAG. THIS INDICATED THAT THE URINE BAG AND THE CATHETER WERE COMPATIBLE. IN CURRENT STANDARD OPERATING PROCEDURE, 100% WATER LEAK TEST WILL BE PERFORMED AFTER FUNNEL INJECTION MOLDING PROCESS AS PER SPM-A51-002. DEFECTIVE CATHETER WILL BE DETECTED AND CULLED OUT DURING THIS PROCESS. UPON COMPLETION OF ASSEMBLY PROCESS, THE FINISHED CATHETER WILL BE AGAIN SUBJECTED TO 100% BALLOON INSPECTION AND 20 MINUTES LEAK TEST. CATHETER WITH DEFECTIVE BALLOON WILL BE CULLED OUT. BASED ON THE INVESTIGATION CONDUCTED ON THE RETURNED CATHETER, NO SIGN OF LEAKAGE OR OTHER ABNORMALITY WAS OBSERVED WITHIN THE CATHETER. THE CATHETER WAS ABLE TO FUNCTION AS PER INTENDED. ALTHOUGH THE URINE BAG USED WAS NOT PART OF TELEFLEX PRODUCT, NO LEAK WAS FOUND BETWEEN THE FUNNEL AND THE CONNECTOR OF THE URINE BAG WHICH INDICATED THAT THERE WAS NO COMPATIBILITY ISSUE. 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.

    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 (B)(6) - LOT NUMBER UNKNOWN. - 1 CATHETER (B)(6) - LOT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682941 BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL EZL TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male N/A.| N/A.