BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 LOW PRESSURE POWER INJECTION EXTENSION SET

    MDR report key: 17490763 · Received August 9, 2023

    Report

    Report Number
    1649914-2023-00021
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 10, 2023
    Report Date
    August 9, 2023
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    UDI-DI
    00634624959071
    PMA / PMN Number
    K162804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REPRESENTATIVE FROM QUEST WENT TO THE CUSTOMER'S LOCATION TO DETERMINE A POSSIBLE ROOT CAUSE FOR THE REPORTED PRODUCT FAILURE. THE REPRESENTATIVE WAS ABLE TO COMPLETE 4 CASES WITH THE CUSTOMER'S BLOOD COLLECTION DEVICE WITH NO ISSUES. THE ROOT CAUSE WAS DETERMINED TO BE A USAGE ERROR. QUEST HAS CONCLUDED THE INVESTIGATION. QUEST WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 0

    QUEST MEDICAL HAS NOT YET RECEIVED THE AFFECTED DEVICE FROM AVIA VASCULAR FOR INVESTIGATION. QUEST WILL FILE A SUPPLEMENTAL REPORT AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO QUEST MEDICAL BY AVIA VASCULAR OF AN ALLEGED DEFECT WITH PRODUCT CODE 95907. THE REPORT INDICATED THAT A LEAK HAD OCCURRED IN THE LINE. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905334 Q2 LOW PRESSURE POWER INJECTION EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 95907 67356 00634624959071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown