BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 16768842 · Received April 19, 2023

    Report

    Report Number
    1416980-2023-01841
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT # - POTENTIAL LOTS WERE R22J11024, R23A24017, R22L07024 AND R22L10024. G1: DEVICE MANUFACTURER ADDRESS 1: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. PRESSURE AND CLEAR PASSAGE TESTS WERE PERFORMED, AND A LEAK WAS OBSERVED BETWEEN THE DISKS OF THE CHECK VALVE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS A MANUFACTURING RELATED ISSUE. A BATCH REVIEW WAS CONDUCTED FOR THE SUSPECTED LOT NUMBERS: R22J11024, EXPIRATION DATE 10/12/2027, MANUFACTURED 10/12/2022 . R22L07024, EXPIRATION DATE 12/07/2024, MANUFACTURED 12/8/2022. R22L10024, EXPIRATION DATE 12/12/2024, MANUFACTURED 12/13/2022 . R23A24017, EXPIRATION DATE 01/25/2025, MANUFACTURED 10/26/2023. THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE ISSUE WAS IDENTIFIED DURING AN UNKNOWN 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
    1937221 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown