BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 20049026 · Received August 23, 2024

    Report

    Report Number
    9610711-2024-00211
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    December 20, 2024
    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 DIDN'T FIND OTHER COMPLAINT REGARDING THE LOT NUMBER 9505144.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND OTHER COMPLAINTS REGARDING THE LOT NUMBER 9505144. THE SAMPLE WAS RECEIVED ON 1ST AUGUST. AFTER DISINFECTION WE CAN OBSERVED THE BALLOON WAS BURST WITHOUT MISSING PART. BURST ISSUE OF SILICONE BALLOON IS KNOWN BUT ACCORDING TO THE AVAILABLE INFORMATION WE CANNOT CONCLUDE ON A SPECIFIC ROOT CAUSE IN THIS CASE. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON PRODUCT: FOLYSIL DHF, DEFECT, BURST FROM SEPTEMBER 2020 TO SEPTEMBER 2024, 178 SIMILAR CASES WERE FOUND. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, URINARY CATHETER AA6116 CATHETERIZED THE PREVIOUS DAY WAS FOUND IN THE PATIENT'S PROTECTION, DEFLATED BALLOON. THE BALLOON HAD BEEN TESTED PRIOR TO INSERTION AND INFLATED WITH 15ML OF PPI WATER. THE CATHETER WAS DISCARDED AND THE NURSE WHO REPLACED IT WITH A CH18. THE CATHETER BALLOON WAS TESTED BEFORE INSERTION THEN INFLATED WITH 15ML OF PPI WATER. THE FOLLOWING DAY (25/07), THE CATHETER WAS FOUND IN THE PATIENT'S PROTECTION. THE TEAM DECIDED TO TEST THE BALLOON BY TRYING TO INJECT PPI WATER, WHICH CAME OUT OF THE BALLOON THROUGH A TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698695 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9505144_AA61181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown