BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20521847 · Received October 24, 2024

    Report

    Report Number
    9610711-2024-00297
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 4, 2024
    Report Date
    February 21, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127230
    PMA / PMN Number
    K233411
    Adverse Event
    Yes
    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 COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 9041085.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9041085. ON 25TH OCTOBER, WE RECEIVED ONE USED SAMPLE. AFTER DECONTAMINATION, WE OBSERVED THAT THE BALLOON WAS BURST, PIERCED BY THE MEDICAL TEAM BECAUSE IT COULD NOT DEFLATE THE BALLOON. IN ADDITION, THE VALVE WAS CUT OFF. IN THIS SITUATION, THE SAMPLE DOES NOT ALLOW US TO IDENTIFY A ROOT CAUSE EXPLAINING THE DIFFICULTY OF DEFLATION. BALLOON DEFLATION ISSUE IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE. QUALITY DATABASE WAS CHECKED AND REVEALED A CORRECTIVE AND PREVENTIVE ACTION CAPA-000152. "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS" WAS OPENED AND MONTHLY MONITORING. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS OUR TREND IS NOT INCREASING. A SIMILAR CASE STUDY WAS PERFORMED BASED ON FOLYSIL SILICONE CATHETER, SAME DEFECT:"BALLOON DEFLATION DIFFICULT/IMPOSSIBLE" OVER LAST FOUR YEAR: 52 SIMILAR CASES WERE FOUND. THE EVALUATION HAS SHOWED THAT RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE IN THE STATE OF ART. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN ATTEMPTING TO REMOVE THE CATHETER THE BALLOON WAS UNABLE TO BE DEFLATED WITH A SYRINGE. TO DEFLATE THE BALLOON THE BALLOON WAS PIERCED BY ECHOGRAPHY BY ABDOMINAL PUNCTION. THE PATIENT HAD TO BE SEDATED TO ALLOW BLADDER PUNCTION. THE EXIT FROM THE POST-INTERVENTION ROOM WAS DELAYED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, WHEN ATTEMPTING TO REMOVE THE CATHETER THE BALLOON WAS UNABLE TO BE DEFLATED WITH A SYRINGE. TO DEFLATE THE BALLOON THE BALLOON WAS PIERCED BY ECHOGRAPHY BY ABDOMINAL PUNCTION. THE PATIENT HAD TO BE SEDATED TO ALLOW BLADDER PUNCTION. THE EXIT FROM THE POST-INTERVENTION ROOM WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579486 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9041085_AA61121002 03600040127230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention