BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 21207331 · Received January 22, 2025

    Report

    Report Number
    9610711-2025-00016
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    October 18, 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

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE FOUND ONE SIMILAR COMPLAINT REGARDING THE LOT NUMBER 9041085. REFER TO (B)(4); THE PRODUCT REFERENCE AA61121002 LOT NUMBER 9041085 WAS MADE IN FEBRUARY 2023 FOR (B)(4) PIECES. THE EXPIRY DATE IS FEBRUARY 2028. THE PRODUCT REFERENCE AA61121002 LOT NUMBER 9041085 WAS MADE BY AN INTERMEDIATE PRODUCT REFERENCE AA611280 LOT 8851123. THIS INTERMEDIATE WAS MANUFACTURED BY OUR TUNISIAN SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. THE INTERMEDIATE WAS MADE WITH BALLOON COMPONENT REFERENCE YS388060 LOT NUMBER 8788846. ONE USED SAMPLE RECEIVED IN OCTOBER. AFTER VISUAL OBSERVATION WE NOTED THAT BALLOON STILL INFLATED AND WE OBSERVED A LIQUID WITH WHITE SUSPENSION INSIDE. THIS SUSPENSION CAN BLOCKED BALLOON 'S DEFLATION. THE ORIGIN OF THE SUSPENSION IS NOT KNOWN. ACCORDING TO THE INVESTIGATION PERFORMED QUALITY DATABASE WAS CHECKED AND REVEALED NO ANOMALY REGISTERED RELATIVE TO THIS ISSUE. A SIMILAR CASE STUDY WAS PERFORMED BASED ON FOLYSIL PRODUCT, DEFECT PARTICLE IN BALLOON FROM NOVEMBER 2020 TO NOVEMBER 2024, NO SIMILAR CASE WAS FOUND. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ 247 - RISKS IDENTIFIED 12611 (HAZARDOUS SITUATION: CATHETER WITHDRAWAL IS IMPOSSIBLE (OR WITH DIFFICULTY)) THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART LEVEL. BASED ON THIS, WE CAN CONCLUDE THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS 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 FOUND ONE SIMILAR COMPLAINT REGARDING THE LOT NUMBER 9041085.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE URINARY CATHETER, THE BALLOON COULD NOT BE DEFLATED. THE BALLOON WAS DEFLATED VERY SLOWLY, OVER 1 HOUR, WITH THE PATIENT UNDER MEOPA GAS. IT WAS POSSIBLE TO INJECT PPI WATER, BUT NOT TO REMOVE IT. THE CATHETER WAS INSERTED 7 DAYS LATER, INFLATING THE BALLOON TO 10CC WITH SERUM.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN REMOVING THE URINARY CATHETER, THE BALLOON COULD NOT BE DEFLATED. THE BALLOON WAS DEFLATED VERY SLOWLY, OVER 1 HOUR, WITH THE PATIENT UNDER MEOPA GAS. IT WAS POSSIBLE TO INJECT PPI WATER, BUT NOT TO REMOVE IT. THE CATHETER WAS INSERTED 7 DAYS LATER, INFLATING THE BALLOON TO 10CC WITH SERUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843449 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9041085_AA61121002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown