BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLET PORT CLAMP

    MDR report key: 17798157 · Received September 22, 2023

    Report

    Report Number
    1416980-2023-04803
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CHANGE FROM SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE TO CLAMP, LINE CLASSIFICATION CODE: CHANGE FROM KDJ TO FKK UPDATE THE QUANTITY OF DEVICES TO (4) FOUR (PREVIOUSLY REPORTED AS A QUANTITY OF (1) ONE). CATALOGUE #: WAS UPDATED FROM EK5853 TO 5C4527. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OUTLET PORT CLAMP WAS NOT EFFECTIVE. THE TUBING DRIPPED AFTER IT WAS CLIPPED. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122873 OUTLET PORT CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA ASKU
    2174981 OUTLET PORT CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown