BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT

    MDR report key: 23043028 · Received September 12, 2025

    Report

    Report Number
    1417592-2025-00469
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 12, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OFR
    UDI-DI
    10888277703384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, "THE PORT TO ATTACH SALINE TO THE DEVICE TO FLUSH THE LINE IS NOT A SNUG FIT, AND THEREFORE SALINE LEAKS ON THE PATIENT" AND THAT THE PROVIDER HAD TO SWITCH TO "OPEN SUCTIONING" DUE TO "LOSS OF PRIMARY FUNCTION WITH LEAKAGE DURING USE" TO "AVERT AIRWAY COMPROMISE." NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, "THE PORT TO ATTACH SALINE TO THE DEVICE TO FLUSH THE LINE IS NOT A SNUG FIT, AND THEREFORE SALINE LEAKS ON THE PATIENT" AND THAT THE PROVIDER HAD TO SWITCH TO "OPEN SUCTIONING" DUE TO "LOSS OF PRIMARY FUNCTION WITH LEAKAGE DURING USE" TO "AVERT AIRWAY COMPROMISE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435739 CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT OFR MEDLINE INDUSTRIES, LP 10888277703384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other