BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACLAMP TUBING CLAMP

    MDR report key: 15186966 · Received August 8, 2022

    Report

    Report Number
    1416980-2022-04108
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 15, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    UDI-DI
    00085412070643
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FIRST NAME: (B)(6).SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNSPECIFIED QUANTITY OF ULTRA CLAMPS CUT THE TUBING OF THE SOLUTION BAGS WHICH RESULTED IN LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS (APD) 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
    302996 ULTRACLAMP TUBING CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA GD909679 00085412070643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DIANEAL