BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 17375371 · Received July 22, 2023

    Report

    Report Number
    1416980-2023-03718
    Event Type
    Malfunction
    Date Received
    July 22, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412048994
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: DEVICE MANUFACTURER ADDRESS 1: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: REMOVE: A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET (PREVIOUSLY REPORTED) AND REPLACE PRODUCT DESCRIPTION WITH AN UNSPECIFIED ACCESS SOLUTION SET. D1: BRAND NAME: REMOVE: CLEARLINK CONTINU-FLO SOLUTION SET (PREVIOUSLY REPORTED) REPLACE WITH NI. D4: CATALOGUE #: REMOVE: 2C8519 (PREVIOUSLY REPORTED) REPLACE WITH NI. D4: LOT #: REMOVE: R21L09086 (PREVIOUSLY REPORTED) REPLACE WITH NI. D4: UNIQUE IDENTIFIER (UDI)#: REMOVE: (B)(4) (PREVIOUSLY REPORTED) REPLACE WITH NI. G4: 510K#: REMOVE: K203609 (PREVIOUSLY REPORTED) REPLACE WITH NI. H10: THE DEVICE WAS 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 · 0

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET DISCONNECTED FROM THE MALE LUER ADAPTER TO THE VASCULAR ACCESS DEVICE. THIS WAS DISCOVERED 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
    2256119 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R21L09086 00085412048994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown