BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYSTEM T-CONNECTOR EXTENSION SET

    MDR report key: 12042673 · Received June 22, 2021

    Report

    Report Number
    1416980-2021-03818
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412004662
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H4, H6 AND H10. 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 NOT RECEIVED FOR EVALUATION; 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: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS REPORTED AS "THE LOT# ON THE SHELF IS (10)UR21B09010". IT IS UNCLEAR IF THIS LOT NUMBER IS THE SAME LOT FROM THE EVENT. . SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET SEPARATED. DURING PATIENT USE, "THE T CONNECTOR BROKE OFF FROM THE DISTAL END NEAR ITS HUB". THE NURSE THEN "PINCHED OFF THE THIN TUBING TO PREVENT THE BACK FLOW OF BLOOD WHILE WAITING FOR DOCTOR TO GIVE THE INTRAVENOUS SEDATION". THE PERIPHERAL IV AND T-CONNECTOR WERE REPLACED. 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
    941360 INTERLINK SYSTEM T-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA UR21B09010 00085412004662

    Patients

    Seq Age Sex Outcome Treatment
    1 NI.