BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 16052738 · Received December 27, 2022

    Report

    Report Number
    1416980-2022-07059
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 29, 2022
    Report Date
    December 27, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL LOT #S: R22I05031, R21J06093, R22G16024, R22G25017, R22H23048. THE EXPIRATION DATE OF THE POTENTIAL LOT # R22I05031 IS 09/05/2027. THE EXPIRATION DATE OF THE POTENTIAL LOT # R21J06093 IS 07/10/2027. THE EXPIRATION DATE OF THE POTENTIAL LOT # R22G16024 IS 07/17/2028. THE EXPIRATION DATE OF THE POTENTIAL LOT # R22G25017 IS 07/25/2028. THE EXPIRATION DATE OF THE POTENTIAL LOT # R22G25017 IS 08/24/2027. DEVICE MANUFACTURER ADDRESS 1: (B)(4). THE POTENTIAL LOT # R22I05031 WAS MANUFACTURED ON 09/06/2022. THE POTENTIAL LOT # R21J06093 WAS MANUFACTURED ON 10/07/2021. THE POTENTIAL LOT # R22G16024 WAS MANUFACTURED ON 07/17/2022. THE POTENTIAL LOT # R22G25017 WAS MANUFACTURED ON 07/26/2022. THE POTENTIAL LOT # R22H23048 WAS MANUFACTURED ON 08/25/2022. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL CONNECTOR OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET SNAPPED OFF INSIDE THE HUB WHILE DISCONNECTING FROM A SMARTSITE EXTENSION SET (NON-BAXTER). THE SET-UP WAS CONNECTED TO A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THIS ISSUE OCCURRED DURING USE WHILE REMOVING THE TUBING FROM THE IV PORT CONNECTOR. 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
    2136264 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE| SMARTSITE EXTENSION SET (NON-BAXTER)