BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CHECK VALVE EXTENSION SET

    MDR report key: 21805368 · Received April 9, 2025

    Report

    Report Number
    3012307300-2025-03991
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 6, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K000942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE PHOTO OF THE DEVICE WAS RECEIVED FOR INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED IN THE IMAGE, WHICH DEMONSTRATED THE REPORTED TUBING SEPARATION. HOWEVER, A ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE OBSERVED CONDITION. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING BROKE DURING INFUSION. THE 173 CM CHECK CALVE TUBING (LOT NUMBER: 6005743) HAD BEEN REPORTED DURING AN INGOING PATIENT INFUSION. THIS HAD BEEN IDENTIFIED AND ADDRESSED PROMPTLY, AND FORTUNATELY, NO HARM HAD COME TO THE PATIENT. HOWEVER, DUE TO THE NATURE OF THIS INCIDENT, CONCERNS HAD BEEN RAISED ABOUT THE POTENTIAL FOR SIMILAR OCCURRENCES THAT COULD COMPROMISE PATIENT SAFETY. ADDITIONALLY, INFORMATION HAD BEEN RECEIVED THAT GEH HAD REPORTED SIMILAR ISSUES WITH THE SAME TUBING, RAISING CONCERNS ABOUT A POTENTIAL RECURRING DEFECT. A PHOTO OF THE DEFECTIVE TUBING HAD BEEN ATTACHED FOR REVIEW. IT WAS NOT REPORTED TO FDA. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814908 CADD CHECK VALVE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6005743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown