BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 17421584 · Received July 29, 2023

    Report

    Report Number
    2523676-2023-00378
    Event Type
    Malfunction
    Date Received
    July 29, 2023
    Report Date
    September 29, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). ONE PHOTOGRAPH AND ONE USED SAMPLE WITHOUT PACKAGING WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH AND RETURNED SAMPLE WERE VISUALLY EVALUATED AND IT WAS NOTED THERE WAS A BROWN PARTICULATE IN FEMALE L.L. CONNECTOR. THE REPORTED DEFECT WAS CONFIRMED. THE DEVICE WAS DISSECTED, AND THE PARTICLE WAS TESTED AND WAS FOUND TO BE CARDBOARD. ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED, A FORMAL AWARENESS TRAINING WAS CONDUCTED WITH ALL APPLICABLE PERSONNEL INVOLVED IN THE ASSEMBLY AND INSPECTION OF THIS PRODUCT. THE PURPOSE OF THIS TRAINING WAS TO REVIEW THE REPORTED INCIDENT AND TO ENSURE ALL PERSONNEL UNDERSTAND AND COMPLY WITH THE ESTABLISHED ASSEMBLY AND INSPECTION PROCESSES. ALL AVAILABLE INFORMATION REGARDING THIS OCCURRENCE HAS BEEN FORWARDED TO THE APPROPRIATE MANUFACTURING BUSINESS UNIT IN ORDER TO HEIGHTEN AWARENESS. 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. IN ADDITION, REVIEW OF THE BATCH HISTORY RECORDS WAS ALSO PERFORMED FOR THE REPORTED LOT NUMBER AND NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED DURING THE MANUFACTURING PROCESS OR FINAL INSPECTIONS. 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: DEPARTMENT OPENED A CARESITE SMALLBORE DOUBLE EXTENSION SET (B. BRAUN MEDICAL INC) TO USE WITH A CANNULA WHEN THEY NOTICED THAT THE EXTENSION SET HAD A PIECE SMALL BROWN MATERIAL IN IT. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327513 CARESITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061820029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown