BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    105" ADMIN SET 20 DP, W/2 Y SITE, CV

    MDR report key: 12625963 · Received October 13, 2021

    Report

    Report Number
    9616066-2021-52214
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 16, 2021
    Product Code
    FPA
    UDI-DI
    00814371020112
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED. MODEL: A2-80072 LOT NUMBER: 20076342 QTY: (B)(4) QN/DEVIATIONS: ZERO MFG DATE: JUL/19/2020 *NO QNS WERE FOUND FOR THE REPORTED LOT. TREND REVIEW: A TREND REVIEW WAS PERFORMED FOR MODEL A2-80072 AND NO QNS RELATED TO THIS FAILURE MODE WERE FOUND IN A 12-MONTHS PERIOD (SEPTEMBER 22ND, 2020 TO SEPTEMBER 22ND, 2021). A TREND REVIEW WAS PERFORMED FOR MODEL A2-80072 AND ONE ADDITIONAL COMPLAINT (B)(4) RELATED TO THIS FAILURE MODE WAS FOUND IN A 12-MONTHS PERIOD (SEPTEMBER 22ND, 2020 TO SEPTEMBER 22ND, 2021). INVESTIGATION SUMMARY: SAMPLE FOR THE REPORTED FAILURE MODE WAS REQUESTED, HOWEVER, ON SEPTEMBER 22ND , 2021, WAS CONFIRMED THAT NO SAMPLES WILL BE RECEIVED, THEREFORE, NO INVESTIGATION WAS PERFORMED SINCE NO SAMPLES OR PICTURE WAS RECEIVED FOR EVALUATION AND NO FURTHER INFORMATION REGARDING TO THE FAILURE WAS PROVIDED FROM CUSTOMER. ROOT CAUSE DEFINITION: NO ROOT CAUSE DEFINITION WAS DETERMINED DUE TO THE CUSTOMER NOT PROVIDING A SAMPLE FOR EVALUATION AND NO FURTHER INFORMATION WAS PROVIDED. CORRECTIVE AND PREVENTIVE ACTIONS: NO PREVENTIVE AND CORRECTIVE ACTIONS REQUIRED SINCE THE FAILURE MODE COULD NOT BE CONFIRMED. WE WILL CONTINUE TO MONITOR OUR CUSTOMER FEEDBACK PROCESSES FOR ANY SIMILAR INCIDENCES, IMPLEMENT ANY CORRECTIVE ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 105" ADMIN SET 20 DP, W/2 Y SITE, CV WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED THAT AN ADMINISTRATION SET MODEL A2-80072 LOT 20016342 WOULD NOT PRIME. OPERATOR RN. MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523900 105" ADMIN SET 20 DP, W/2 Y SITE, CV INTRAVASCULAR ADMINISTRATION SET FPA 20076342 00814371020112

    Patients

    Seq Age Sex Outcome Treatment
    1