BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLANT POST-OP 3-W SILICONE FOLEY,CYL.

    MDR report key: 10471831 · Received August 31, 2020

    Report

    Report Number
    8040412-2020-00173
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 2, 2020
    Report Date
    August 3, 2020
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO BATCH NUMBER PROVIDED THEREFORE DHR COULD NOT BE CONDUCTED. IFU STATED THAT URINARY TRACT INFECTIONS, URGENCY AND TENESMUS, IRRITATIONS OF CATHETER DUE TO ENCRUSTRATION ARE DOCUMENTED POTENTIAL COMPLICATIONS. PLUS INCORRECTLY POSITIONED CATHETER CAN CAUSE URETHRAL DAMAGE IF THE BALLOON IS INFLATED WITHIN URETHRA. THERE IS NO SAMPLE RETURNED FOR THIS COMPLAINT THEREFORE INVESTIGATION WAS DONE BASED ON COMPLAINT DESCRIPTION AND IFU REFERENCE. ACCORDING TO THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT THE SELECTION OF CATHETER SIZE WAS WRONGLY PICKED. BIGGER SIZE WILL CAUSE MORE CONTACT WITH THE URETHRA AND MIGHT BE CAUSING THE PHYSICAL RESPONSE. SUGGEST TO CONSULT WITH MEDICAL EXPERTIES ON APPROPRIATE CATHETER SIZE BEFORE USED ON PATIENT. COMPLAINT NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RE-CATHETERIZED WITH A CATHETER 3V 18 CH AFTER THE PATIENT PULLED OUT THE PREVIOUS ONE. A HEMORRHAGE WAS OBSERVED THE ORIGIN OF WHICH WAS OBVIOUSLY URETHRAL GIVEN THE CIRCUMSTANCES OF DE-CATHETERIZATION/RE-CATHETERIZATION. CLINICAL CONSEQUENCES: THE PATIENT WAS RE-CATHETERIZED WITH SMALLER SIZE CATHETER(16CH).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RE-CATHETERIZED WITH A CATHETER 3V 18 CH AFTER THE PATIENT PULLED OUT THE PREVIOUS ONE. A HEMORRHAGE WAS OBSERVED THE ORIGIN OF WHICH WAS OBVIOUSLY URETHRAL GIVEN THE CIRCUMSTANCES OF DE-CATHETERIZATION/RE-CATHETERIZATION. CLINICAL CONSEQUENCES: THE PATIENT WAS RE-CATHETERIZED WITH SMALLER SIZE CATHETER(16CH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939583 BRILLANT POST-OP 3-W SILICONE FOLEY,CYL. EZL TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1