BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 18809353 · Received February 29, 2024

    Report

    Report Number
    9610711-2024-00050
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 31, 2024
    Report Date
    July 2, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040128381
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 ANOTHER COMPLAINT ON THE LOT N° 8559622 (B)(4). THE AA63101002 LOT 8559622 HAS BEEN PACKAGED WITH INTERMEDIATE PRODUCTS REF (B)(4) LOT 7983323 IN MAY 2023 AND THE EXPIRY DATE IS MAY 2028. THE AA631080 LOT 7983323 HAS BEEN MANUFACTURED BY OUR TUNISIAN SITE.(INFORMED) CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT.

    Additional Manufacturer Narrative · 0

    UNFORTUNATELY, NO SAMPLE WAS RECEIVED FROM THE CUSTOMER, AND WE CANNOT GO FURTHER THAN THE DOCUMENTARY INVESTIGATION WHICH REVEALS ONE NON-CONFORMITY RECORDED DURING PRODUCTION. CHECKING THE QUALITY DATABASES REVEALED A CORRECTIVE AND PREVENTIVE ACTION POSSIBLY IN RELATION WITH THE DESCRIBED ISSUE. THE TRENDING FOR BALLOON BURSTING IS SPECIFICALLY MONITORED. A SIMILAR CASE STUDY BASED ON ITEM NUMBER AA6310 AND DEFECT BALLOON OVER THE LAST FOUR YEARS: TWO SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED, AND CONCLUDED 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.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION UPON CHECKING THE FOLEY BALLOON IT WAS DIFFICULT TO INFLATE AND THE WATER INSERTED INTO THE BALLOON COULD NOT BE WITHDRAWN. CATHETER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498140 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8559622_AA63101002 03600040128381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown