BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI

    MDR report key: 17684074 · Received September 5, 2023

    Report

    Report Number
    9617594-2023-00648
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    June 30, 2023
    Report Date
    August 7, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THE PORT AT THE PATIENT HUB CRACKED OUT OF PACKAGE. WHEN GOING TO ATTACH THE ITEM 12517-01, THE NURSE NOTICED THAT THE PORT AT THE PATIENT HUB WAS CRACKED. THEY WERE ABLE TO GET ANOTHER SET AND UTILIZE THAT, BUT CARE WAS DELAYED WITH NO ADVERSE REACTION. THE EVENT OCCURRED DURING SET UP. THE NURSE WAS SETTING UP THE IV ON THE PATIENT. THERE WAS A PATIENT INVOLVED AND NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122883 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown