BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-INFUSER RADIATION STERILIZED EXTENSION SETS

    MDR report key: 11793755 · Received May 7, 2021

    Report

    Report Number
    1416980-2021-02755
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    March 14, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6 (REPLACE B17 WITH B01, C20 WITH C19, D15 WITH D14) AND H10. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SET HAD A MALE AND FEMALE LUER AT THE END OF EACH SIDE OF THE TUBING; NO ABNORMALITIES WERE IDENTIFIED. FUNCTIONAL TESTING INCLUDING PRESSURE AND CLEAR PASSAGE TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO B5, D1, D4, G1 (DEVICE MANUFACTURER INFORMATION), G4, AND H6. B5: DESCRIBE EVENT OR PROBLEM: THE AFFECTED PRODUCT IS ¿MINI-INFUSER MICROBORE EXTENSION SET¿, PREVIOUSLY SUBMITTED AS ¿UNSPECIFIED MICROBORE EXTENSION SET¿. D1: BRAND NAME: ¿MINI-INFUSER RADIATION STERILIZED EXTENSION SETS¿, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE #: ¿2C9201¿, PREVIOUSLY SUBMITTED AS ¿ASKU¿. G1: DEVICE MANUFACTURER INFORMATION: ¿BAXTER HEALTHCARE - AIBONITO RD 721 KM 0 3 PO BOX 1389, AIBONITO 00705 PUERTO RICO¿, PREVIOUSLY SUBMITTED AS ¿BAXTER HEALTHCARE CORPORATION¿. G4: PMA/510K # OR BLA #: ¿K811078¿, PREVIOUSLY SUBMITTED AS ¿NI¿. 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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED MICROBORE EXTENSION SET DISCONNECTED ON A PATIENT. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP WHILE IN USE ON A PATIENT. 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
    685113 MINI-INFUSER RADIATION STERILIZED EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown