BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE

    MDR report key: 11786920 · Received May 6, 2021

    Report

    Report Number
    2523676-2021-00106
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    February 26, 2021
    Report Date
    June 28, 2021
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964187971
    PMA / PMN Number
    K955585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. THE DEFECT CANNOT BE CONFIRMED DUE TO NOT HAVING ANY EVIDENCE TO SUPPORT THE REPORTED INCIDENT. RETAINED UNITS WERE EVALUATED AND PASSED THE INTERNAL TESTING. SINCE A SAMPLE WAS NOT RETURNED FOR EVALUATION, THE EXACT ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. 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. 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 · 1

    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 · 1

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING INFUSION OF CARBOPLATIN, IT WAS NOTICED THAT THERE WAS A LEAK IN THE TUBING. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682592 ULTRASITE SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. US1921 0061748459 04046964187971

    Patients

    Seq Age Sex Outcome Treatment
    1