BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR

    MDR report key: 15106268 · Received July 26, 2022

    Report

    Report Number
    1416980-2022-03842
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED BETWEEN JULY 23, 2022 TO JULY 25, 2022. INITIAL REPORTER ADDRESS: (B)(6). DEVICE MANUFACTURER ADDRESS 1: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO B3: THIS EVENT OCCURRED BETWEEN JUNE 23, 2022 TO JUNE 25, 2022 (PREVIOUSLY SUBMITTED AS JULY 23, 2022 TO JULY 25, 2022. H10: THE DEVICES WERE 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 · 0

    IT WAS REPORTED THAT THREE (3) ONE-LINK NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE LEAKING. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿LEAKING FROM THE U¿. THE LEAK WAS OBSERVED WHILE PRIMING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356612 EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown