BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH

    MDR report key: 22185918 · Received June 11, 2025

    Report

    Report Number
    9615050-2025-00288
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    February 4, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005650
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED 14687-15 PRIMARY PLUM SET FOR INSPECTION. THE TUBING WAS SEPARATED FROM THE Y-CLAVE. THE BOND AREA WAS EXAMINED UNDER UV LIGHT AND THE UV MARKER SHOWED GAPS IN SOLVENT COVERAGE. THE TUBING AND BOND POCKET WERE MEASURED AND FOUND TO MEET DESIGN SPECIFICATIONS. THE REPORTED COMPLAINT OF CRACK ON CONNECTOR CANNOT BE CONFIRMED, HOWEVER AS RECEIVED THERE IS TUBING SEPARATION FROM THE Y CLAVE. THE PROBABLE CAUSE OF THE SEPARATED TUBING IS DUE TO INSUFFICIENT SOLVENT APPLIED DURING MANUAL ASSEMBLY. A DHR LOT # AND RELEVANT COMMODITIES WERE REVIEWED; THE FOLLOWING DISCREPANCY WAS IDENTIFIED: EXCEPTION TYPE: NCMR. DOCUMENT ID#: (B)(4). LOT #: 13857689. DISCREPANCY: "02/05/2024, SHIFT A1. MQA INSPECTOR FOUND DAMAGE INSIDE OF Y-LEG AT JUNCTION. LOT # 13857689, P/N: R1-3345, CONNECTOR, Y-SPIKE, 2 WINDOW, .132 MOLD: 4354, PRESS: 37, CAVITY: 30, QTY: 47,500. PER QP00-00033: 2.1 FUNCTIONALLY CRITICAL ATTRIBUTE: A PROPERTY OF A COMPONENT OR DEVICE WHOSE NON-CONFORMANCE WOULD REASONABLY BE EXPECTED TO CAUSE A PERFORMANCE FAILURE IN THE END PRODUCT. BRACKETING COMPLETE AND TOTES 137-155 HAVE BEEN QUARANTINED." E1 INITIAL REPORTER PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH WHERE IT WAS REPORTED THERE WAS A CRACK ON THE CONNECTOR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM. INVESTIGATION WAS COMPLETED ON 05/15/2025. NO CRACK WAS NOTED TO BE FOUND HOWEVER THERE WAS A SEPARATION OF THE TUBING FROM THE Y-CLAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87546 PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 13899204 10887787005650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown