BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE

    MDR report key: 17627099 · Received August 25, 2023

    Report

    Report Number
    3006260740-2023-03710
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 25, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    PMA / PMN Number
    K060812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, QXR HAVE EXPERIENCED SOME WEEPING/LEAKING OF CONTRAST FROM THE END CAP ON THE SIDE PORT OF THE POWERLOC NEEDLES. THEY INFORM THIS HAS HAPPENED DESPITE EFFORTS TO ENSURE THIS CAP IS TIGHT. NO PATIENT SERIOUS INJURY OR HARM REPORTED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803307 POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A ASGUFC074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other