BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACLAMP TUBING CLAMP

    MDR report key: 18586392 · Received January 26, 2024

    Report

    Report Number
    1416980-2024-00184
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Report Date
    February 28, 2024
    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

    CORRECTION B5: CHANGE TO AN UNSPECIFIED QUANTITY OF UNITS (PREVIOUSLY REPORTED AS ONE UNIT). ADDITIONAL INFORMATION WAS ADDED TO B5, H6 AND H10. B5: THE CUSTOMER REPORTED THE CLAMPS STOPPED WORKING PROPERLY AFTER SEVERAL USES. H10: 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 THE ULTRA PORT CLAMP WAS NOT EFFECTIVE AND NOT CLOSING THE LINE ENOUGH. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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
    1899870 ULTRACLAMP TUBING CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown