BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK LUER ACTIVATED VALVE

    MDR report key: 10528357 · Received September 14, 2020

    Report

    Report Number
    1416980-2020-05657
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO B5, D1, D4, D10, G1, G5, H3 AND H6. B5. THE AFFECTED PRODUCT IS CLEARLINK SYSTEM NON-DEHP SOLUTION SET, PREVIOUSLY SUBMITTED AS ACCESS SETS. D1: BRAND NAME: CLEARLINK LUER ACTIVATED VALVE PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE #: 2R8403 PREVIOUSLY SUBMITTED AS ¿ASKU¿. G1: THE EXACT DEVICE MANUFACTURER INFORMATION WAS ADDED. G5: PMA/510K #: K112893 PREVIOUSLY SUBMITTED AS ¿NI¿. H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED USING THE NAKED DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. DIMENSIONAL TEST AND PULL TEST WAS PERFORMED AND NO ISSUES NOTED. ADDITIONALLY, A FUNCTIONAL LEAK TEST WAS PERFORMED WHICH OBSERVED A CUT SLICE HOLE ON THE TUBING. NO ADDITIONAL DEFECT WAS OBSERVED. THE CAUSE OF THE CUT SLICE HOLE WAS DUE TO A MANUFACTURING RELATED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN QUANTITY OF ACCESS SETS HAD A BLUE SLIDE CLAMP THAT BROKE. THIS ISSUE WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. 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
    993975 CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1