BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 9938722 · Received April 8, 2020

    Report

    Report Number
    1416980-2020-02065
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    May 8, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412048918
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS ADDED: CORRECTION: THE DEVICE WAS RECEIVED INSIDE A PLASTIC BIOHAZARD BAG FOR EVALUATION. THE USED SAMPLE HAD AN UNKNOWN WHITE SOLUTION IN THE FLUID PATH AND WAS CONTAMINATED WITH BLOOD. A VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED A BURST NEAR THE TWO PIECE LUER LOCK ASSEMBLY. DUE TO THE NATURE OF THE RETURNED SAMPLE, NO ADDITIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER THE PROBABLE CAUSE WAS END USER RELATED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 A CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SET THAT WAS ATTACHED TO A PATIENT'S IV MALFUNCTIONED; FURTHER DESCRIBED AS DURING COMPUTED TOMOGRAPHY ANGIOGRAPHY THE J LOOP SPLIT AND RESULTED IN A LEAK OF CONTRAST. PRIOR TO THE PROCEDURE, LABS WERE TAKEN AND A J LOOP WAS ATTACHED AND THE SET FLUSHED WELL. THERE WAS NO 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
    402112 CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA UR20A29086 00085412048918

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR