BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21069691 · Received January 3, 2025

    Report

    Report Number
    9610711-2025-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 12, 2024
    Report Date
    April 11, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REFERENCE AA61144002 LOT NUMBER 9851654 WAS MANUFACTURED WITH AN INTERMEDIATE PRODUCT HA611479 LOT NUMBER 9406485 & 9291326. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. THE INTERMEDIATE WAS MADE BY A BALLOON COMPONENT REFERENCE YS388160 LOT NUMBER 9448718 & 9328670. ACCORDING TO THE AVAILABLE INFORMATION, WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. THE QUALITY DATABASE WAS CHECKED AND REVEALED A CORRECTIVE AND PREVENTIVE ACTION FOR "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS" AND IS MONITORED MONTHLY. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS OUR TREND IS NOT INCREASING AND THE THRESHOLD IS NOT EXCEEDED. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND ANY OTHER COMPLAINTS ON LOT NUMBER 9851654. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN THE BALLOON WAS TESTED BEFORE INSTALLATION, IT REMAINED INFLATED. THE CATHETER WAS DISCARDED. IT WAS NOTED IF THE CATHETER HAD BEEN INSERTED WITHOUT TESTING THE BALLOON, REMOVAL OF THE CATHETER WOULD HAVE BEEN TRAUMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775359 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9851654_AA61144002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown