BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING

    MDR report key: 18446149 · Received January 4, 2024

    Report

    Report Number
    9610711-2024-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 1, 2023
    Report Date
    June 19, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040260890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9143129. THE PRODUCT REFERENCE XB63221002 LOT NUMBER 9143129 WAS MANUFACTURED WITH AN INTERMEDIATE PRODUCT XB632280 LOT NUMBER 8751057. THIS INTERMEDIATE WAS MADE WITH BALLOON COMPONENT REFERENCE YS385270 LOT NUMBER 8683742 & 8683745 AND TUBE COMPONENT YSC72260 LOT NUMBER 8613264 THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. SUBCONTRACTOR SEND US A DOCUMENTARY INVESTIGATION WHICH REVEALED NO ANOMALY REGISTERED DURING PRODUCTION. IN DECEMBER, WE RECEIVED ONE CATHETER. A VISUAL EXAMINATION WAS PERFORMED AND PRODUCT WAS VISUALLY CONFORMED. EYES ARE PRESENT AND NO DEFECT WAS VISUALLY DETECTED. FUNCTIONALITY WAS TESTED: - INFLATION AND DEFLATION BALLOON ARE CONFORMED, NO DIFFICULTY TO INFLATE AND DEFLATE, BALLOON WAS OK. - DRAINAGE TEST WAS DONE AND NO ISSUE WAS MET, LIQUID CAN PASS THROUGH THE CATHETER WITHOUT DIFFICULTY, ACCORDING TO THE INVESTIGATION PERFORMED QUALITY DATABASES WAS CHECKED AND REVEALED NO ANOMALY IN RELATION TO THE DESCRIBED DEFECT A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER, XB63 SAME DEFECT CATHETER CLOGGED, ONE OTHER SIMILAR CASE WAS FOUND ((B)(4)). A CLINICAL EVALUATION WAS ALSO PERFORMED AND CONCLUDE: SUCH INCIDENT OF CLOGGED PROSTATIC CATHETER REF. XB63201002 & XB63221002 WITHOUT ANY CLINICAL CONSEQUENCE REPORTED EXCEPT FOR URINE LEAKAGE AT THE LEVEL OF THE MEATUS, IS SEVERITY 3 IN THE WORST-CASE OF RE-INTERVENTION FOR CHANGE OF CATHETER, NOT REQUIRING A CLINICAL ASSESSMENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER APPEARED TO BE CLOGGED. THE URINE FLOWED INTO THE MEATUS AND NOT INTO THE TUBE. THERE WAS LEAKAGE OF URINE AND INEFFECTIVENESS OF THE CATHETER. THE CATHETER WAS CHANGED SUCCESSFULLY.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER APPEARED TO BE CLOGGED. THE URINE FLOWED INTO THE MEATUS AND NOT INTO THE TUBE. THERE WAS LEAKAGE OF URINE AND INEFFECTIVENESS OF THE CATHETER. THE CATHETER WAS CHANGED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585943 HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9143129_XB63221002 03600040260890

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown