BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 22304558 · Received June 22, 2025

    Report

    Report Number
    2521402-2025-00139
    Event Type
    Malfunction
    Date Received
    June 22, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 20, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964186165
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO PHOTOGRAPHS OF THE IV SET AND ONE PHOTOGRAPH OF THE BLISTER PACKAGING WERE PROVIDED FOR EVALUATION. UPON EVALUATION OF THE PROVIDED EVIDENCE, BLOOD LEAKAGE AT THE BONDED JOINT BETWEEN THE TUBING AND THE BOTTOM OF THE FILTER HOUSING WAS OBSERVED. THE REPORTED ISSUE WAS CONFIRMED. FIVE RETAINS FROM THE REPORTED LOT NUMBER WERE TESTED AND PASSED PER SPECIFICATION. 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. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO OPERATOR ERROR DURING THE MANUAL SOLVENT APPLICATION PROCESS OF THE PRODUCT. IT APPEARS THAT INSUFFICIENT SOLVENT WAS APPLIED TO THE TUBING DURING THE BONDING PROCESS. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: TUBING LEAKING. DETAILED INQUIRY DESCRIPTION: BLOOD TUBING LEAKING BY Y-SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314915 INFUSOMAT® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 00VL978988 04046964186165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown