BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFSITE®

    MDR report key: 22792963 · Received August 13, 2025

    Report

    Report Number
    2521402-2025-00411
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04022495769862
    PMA / PMN Number
    K942988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO USED SAMPLES WERE PROVIDED FOR INVESTIGATION. UPON EVALUATION OF THE UNITS, NO VISUAL DEFECTS WERE OBSERVED. THE SAMPLE WAS LEAK TESTED WITH NO LEAKAGE NOTED. THE REPORTED ISSUE WAS NOT CONFIRMED. ALL A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED AND PASSED PER SPECIFICATION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: BLOOD SEEN TO BE OOZING FROM THE SAFSITE VALVE AFTER DISCONNECTION OF HEIDELBERG EXTENSION TUBING. CAP PLACED ON SAFSITE VALVE TO STOP THE BACK FLOW OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75975 SAFSITE® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 0061968348 04022495769862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown