BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 17551497 · Received August 15, 2023

    Report

    Report Number
    1416980-2023-04099
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE AND D10 - THE EVENT OCCURRED ON AN UNSPECIFIED DATE ON (B)(6) 2023. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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

    CORRECTION G1: CHANGE TO MANUFACTURING LOCATION (PREVIOUSLY REPORTED AS BAXTER HEALTHCARE CORPORATION WITH NO LOCATION). H10: UPON FURTHER REVIEW OF THIS REPORT, IT WAS NOTED THAT ALTHOUGH THE CUSTOMER DID NOT PROVIDE THE PRODUCT CODE OR LOT NUMBER, A REGISTRATION NUMBER OF THE PRODUCT WAS PROVIDED WHICH IDENTIFIED THE PRODUCT AS A PRODUCT MANUFACTURED AT THE SÃO PAULO MANUFACTURING FACILITY (OMITTED ON INITIAL REPORT). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED SOLUTION ADMINISTRATION SET WAS LEAKING. THE LEAK WAS FURTHER DESCRIBED AS, ¿EXTRAVASATION OF CHEMOTHERAPY BY THE LATERAL INJECTOR SET¿. THIS EVENT OCCURRED DURING AN UNSPECIFIED PROCESS STEP. 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
    1793935 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED CHEMOTHERAPY