BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL SILICONE CATHETER

    MDR report key: 18802934 · Received February 28, 2024

    Report

    Report Number
    9610711-2024-00047
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K233411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 OTHER COMPLAINT REGARDING THE LOT NUMBER 8408112 ON A LEAKAGE ISSUE (B)(4). THE PRODUCT REFERENCE AA61201002 LOT NUMBER 8408112 WAS MANUFACTURED IN JANUARY 2022 FOR (B)(4) PIECES. THE EXPIRY DATE IS JANUARY 2027. THE PRODUCT REFERENCE AA61201002 LOT NUMBER 8408112 WAS MANUFACTURED WITH AN INTERMEDIATE PRODUCT AA612080 LOT NUMBER 8115468. THIS INTERMEDIATE WAS MADE WITH BALLOON COMPONENT REFERENCE (B)(4) LOT NUMBER 7780201. THIS PRODUCT WAS MADE BY OUR SUBCONTRACTOR WHICH WAS INFORMED ABOUT THIS ISSUE. CHECKING THE QUALITY DATABASES REVEALED ONE CORRECTIVE AND PREVENTIVE ACTION: MONITORING CAPA-000152: "BALLOON ISSUES ON FOLYSIL AND SILICONE PROSTATIC CATHETERS". THE TRENDING FOR INFLATION/DEFLATION ISSUE ON FOLYSIL CATHETERS IS SPECIFICALLY MONITORED.

    Additional Manufacturer Narrative · 0

    ON 22ND FEBRUARY, WE RECEIVED AN INVESTIGATION FROM OUR SUBCONTRACTOR: THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. A SIMILAR CASE STUDY WAS PERFOMED BASED ON SAME ITEM NUMBER AA6120, SAME DEFECT "DEFLATION DIFFICULT/IMPOSSIBLE" OVER LAST FOUR YEAR, 1 SIMILAR CASE WAS FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION BALLOON WAS UNABLE TO BE EMPTIED AND THERE WAS A LEAKAGE FROM THE BALLOON.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION BALLOON WAS UNABLE TO BE EMPTIED AND THERE WAS A LEAKAGE FROM THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898280 FOLYSIL SILICONE CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8408112_AA61201002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown