BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT ET CLOSED SUCTION CATHETER

    MDR report key: 23121084 · Received September 23, 2025

    Report

    Report Number
    3006061749-2025-00054
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 21, 2025
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO ADVERSE EVENT WAS REPORTED WE HAVE DECIDED AFTER INTERNAL RISK ASSESSMENT REVIEW TO INVESTIGATE THE INCIDENT. OCCURENCE CALCULATION: NOTE- TOTAL UNITS SOLD AND TOTAL COMPLAINTS USE 12 MONTHS FROM DATE EVEN OCCURRED. IF DATE EVENT OCCURRED IS NOT AVAILABLE USE 12 MONTHS FROM EVENT DATE IN Q-PULSE. CALCULATION EXAMPLE OCCURRED FROM: (B)(6) 2025 SALES DATA: (B)(6) 2024 TO (B)(6) 2025 P9 2024 TO P8 2025 277 (20) + 240 + 1012 (20) + 3590 + 35 = 29,645 SCORE: NA SEVERITY: S0 COMPLAINTS: 0 NOTES-NO SIMILAR OCCURRENCE HAPPENED BETWEEN (B)(6) 2024 TO (B)(6) 2025, THEREFORE SCAR WILL NOT BE INITIATED. NARATIVE: A MEDIUM-RISK COMPLAINT WAS REPORTED TO THE NCA IN RELATION TO CONDENSATE OBSERVED IN A CATHETER BAG. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION, BUT THE CUSTOMER HAS CONFIRMED THEY WILL RETAIN A SAMPLE IF THE ISSUE RECURS. AN EMAIL ACKNOWLEDGING THE COMPLAINT HAS BEEN ATTACHED. BASED ON THE AVAILABLE EVIDENCE[?]INCLUDING THE DEVICE HISTORY RECORD (DHR), PHOTOS, AND VIDEOS[?]THE PROBABLE CAUSE IS ATTRIBUTED TO USER ERROR. THE COMPLAINT IS BEING TRACKED ACCORDINGLY, AND NO FURTHER ACTION IS REQUIRED AT THIS TIME UNLESS ADDITIONAL OCCURRENCES ARE REPORTED.

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO ADVERSE EVENT WAS REPORTED WE HAVE DECIDED AFTER INTERNAL RISK ASSESSMENT REVIEW TO INVESTIGATE THE INCIDENT.

    Description of Event or Problem · 0

    CONDENSATE IN CATHETER BAG WHEN IN USE. NO REPORT OF SERIOUS INJURY / HARM TO PATIENT OR USER, NO REPORT OF INDIRECT HARM, NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE, NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE, NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT, NOT REPORTED AS LIFE THREATENING, NO DEATH REPORTED.

    Description of Event or Problem · 0

    CONDENSATE IN CATHETER BAG WHEN IN USE. NO REPORT OF SERIOUS INJURY/HARM TO PATIENT OR USER. NO REPORT OF INDIRECT HARM. NO REPORT OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. NO REPORT OF HOSPITALISATION - INITIAL OR STAY PROLONGED BY 1 DAY OR MORE. NO REPORT OF SERIOUS INJURY, DISABILITY OR PERMANENT IMPAIRMENT. NOT REPORTED AS LIFE THREATENING. NO DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196205 ADULT ET CLOSED SUCTION CATHETER CATHETER BSY FLEXICARE MEDICAL LTD 231200577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown