BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12340466 · Received August 18, 2021

    Report

    Report Number
    9616066-2021-51831
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 21, 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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/9/2021. H.6. INVESTIGATION: 3 SAMPLES OF THE MODEL A2-80072 WERE RECEIVED, THE SAMPLES WERE VISUALLY INSPECTED, AND NO ISSUES WERE OBSERVED DURING THE INSPECTION. THE THREE SAMPLES WERE TESTED, AND NO OCCLUSION ISSUES WERE FOUND IN TWO (2) OF THEM, HOWEVER, FOR THE REMAINING SAMPLE, THE OCCLUSION WAS EVIDENT DUE TO NO FLOW WAS OBSERVED BETWEEN THE DRIP CHAMBER AND THE TUBING, CONFIRMING THE OCCLUSION IN THE SET. THE OCCLUDED SET WAS REVIEWED WITH THE PROCESS QUALITY ENGINEER, AND IT WAS DECIDED TO CUT THE SET TO IDENTIFY WHERE THE OCCLUSION IS, THE SET WAS CUT IN THE BOTTOM SIDE OF THE DRIP CHAMBER NEAR TO THE VALVE, AND THE OCCLUSION BETWEEN THE DRIP CHAMBER AND THE TUBING WAS NOT OBSERVED. SINCE THE OCCLUSION WAS NOT OBSERVED BETWEEN THE TUBING AND THE DRIP CHAMBER AFTER THE CUT, THE VALVE CHECK WAS TESTED, AND THE OCCLUSION WAS CONFIRMED. A REVISION OF 3 SAMPLES OF THE MODEL A2-80072 WAS CONDUCTED, AND ONE SAMPLES WAS FOUND TO BE OCCLUDED, THE SAMPLES WAS CUT IN THE PARTS TO VERIFY WHERE THE OCCLUSION WAS, HOWEVER, DURING THE VERIFICATION, IT WAS CONFIRMED THAT THE OCCLUSION IN THE A2-80072 WAS RELATED TO THE CHECK VALVE. DHR WAS PERFORMED AND NO QN'S WERE FOUND. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 105" ADMIN SETS 20 DP, W/2 Y SITE, CV HAD FLOW ISSUES AND WERE BLOCKED/OCCLUDED WHILE PRIMING THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED AN EMAIL STATED THAT AN ADMINISTRATION SET MODEL A2-80072 LOT 20095073 SET WOULD NOT PRIME. OPERATOR RN. MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 105" ADMIN SETS 20 DP, W/2 Y SITE, CV HAD FLOW ISSUES AND WERE BLOCKED/OCCLUDED WHILE PRIMING THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED AN EMAIL STATED THAT AN ADMINISTRATION SET MODEL A2-80072, LOT 20095073 SET WOULD NOT PRIME. OPERATOR (B)(6). MEDICATION N/A. PATIENT INVOLVED. PATIENT WAS NOT HARMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232371 105" ADMIN SET 20 DP, W/2 Y SITE, CV INTRAVASCULAR ADMINISTRATION SET FPA 20095073 00814371020112

    Patients

    Seq Age Sex Outcome Treatment
    1