BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLET PORT CLAMP

    MDR report key: 11827002 · Received May 14, 2021

    Report

    Report Number
    1416980-2021-02906
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO 05/14/2021.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHORT NOSE CLAMP FOR THE OUTLET PORT OF A PLASTIC CONTAINER PUT HOLES IN THE TUBING OF THE PLASTIC CONTAINER WHICH RESULTED IN A LEAK. THIS EVENT WAS OBSERVED WHEN THE SHORT NOSE CLAMP WAS USED TO CLAMP THE OUTLET PORT OF A PLASTIC CONTAINER DURING PERITONEAL DIALYSIS THERAPY. THERE WAS NO 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
    721622 OUTLET PORT CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SOLUTION