BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT

    MDR report key: 20991768 · Received December 20, 2024

    Report

    Report Number
    9610711-2024-00351
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 20, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K170422
    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 DIDN¿T FIND OTHER COMPLAINTS ON THE LOT N°9874992 FOR THE REPORTED ISSUE. THIS ISSUE IS DUE TO A PRODUCT ERROR DURING KITTING. THE PACKAGING WITH LABELS INDICATES A JJ BIOSOFT CH7 BUT THE JJ USED FOR THE KITS IS A JJ BIOSOFT CH6. THE 2 KITS MANUFACTURED WERE SENT TO THE SAME CUSTOMER WHO DETECTED THE ISSUE BEFORE USE. THE DISTRIBUTION CENTRE (DC) HAS PERFORMED AN IMMEDIATE RESENSITIZATION OF THE KITTING TEAM. CHECKING THE QUALITY DATABASES REVEALED A CORRECTIVE AND PREVENTIVE ACTION IN CONNECTION WITH THE DESCRIBED DEFECT. THE DC HAS REVIEWED THE ACTIONS AND THE ACTIONS ARE UNDER IMPLEMENTATION. B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, TWO BCAF74, LOT 9874992 WERE RECEIVED. THE OUTSIDE OF THE PACKAGING STATES 7X26, BUT THE INSIDE PEEL-PACKAGING IS 6X26. THEY HAVE PULLED (2) PRODUCTS WITH THE ISSUE OFF THE SHELF; HOWEVER, THEY ARE NOT SURE HOW MANY HAVE BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355574 BIOSOFT DUO DOUBLE LOOP URETERAL STENT KIT UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE FAD COLOPLAST A/S 9874992_BCAF744400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown