BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORBAVIEW SHIELD SYS 2.25" X 2.75" ST

    MDR report key: 23817812 · Received December 16, 2025

    Report

    Report Number
    1824619-2025-00019
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    October 28, 2025
    Report Date
    January 20, 2026
    Manufacturer
    CENTURION MEDICAL PRODUCTS, LP
    Product Code
    KMK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO A5: ETHNICITY. UPDATE TO A6: RACE. UPDATE TO D8: WAS THE DEVICE EVER SERVICED BY A THIRD PARTY? UPDATE TO E1: NAME AND ADDRESS. UPDATE TO E2: HEALTH PROFESSIONAL? UPDATE TO E3: OCCUPATION. UPDATE TO E4: INITIAL REPORTER ALSO SENT REPORT TO FDA? UPDATE TO H10: RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE PICC LINE BECAME DISLODGED, "POTENTIALLY DUE TO AN ISSUE WITH THE DRESSING, AS THE DRESSING WAS STILL COMPLETELY INTACT, BUT THE LINE HAD FALLEN OUT." THE CUSTOMER SAID THE LINE WAS REPLACED. THE CUSTOMER REPORTED THERE WAS NO SERIOUS INJURY RELATED TO THE REPORTED INCIDENT. 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 PICC LINE BECAME DISLODGED, "POTENTIALLY DUE TO AN ISSUE WITH THE DRESSING, AS THE DRESSING WAS STILL COMPLETELY INTACT, BUT THE LINE HAD FALLEN OUT." THE CUSTOMER SAID THE LINE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875124 SORBAVIEW SHIELD SYS 2.25" X 2.75" ST KMK CENTURION MEDICAL PRODUCTS, LP 2025072101

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female Other