BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 18994842 · Received March 28, 2024

    Report

    Report Number
    9610711-2024-00074
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Report Date
    July 2, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040126974
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ONE REGARDING LOT NUMBER 8122981. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. IN APRIL, WE RECEIVED DOCUMENTARY INVESTIGATION FROM OUR SUBCONTRACTOR: THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. WE RECEIVED ONE USED SAMPLE AFTER DISINFECTION WE OBSERVED THAT THE BALLOON HAD BURST BUT NO FRAGMENTS OF IT WAS MISSING. WE ALSO RECEIVED DOCUMENTARY INVESTIGATION FROM OUR SUBCONTRACTOR: THE PROBABLY ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. A RISK MANAGEMENT FILE EVALUATION WAS PERFORMED AND CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST DURING USE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221019 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8122981_AA66201002 03600040126974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown