BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC

    MDR report key: 21994538 · Received May 9, 2025

    Report

    Report Number
    9617594-2025-00963
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    February 24, 2025
    Report Date
    September 7, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709037281
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. SECTION E ADDITIONAL CONTACT: KIM KEMPEN DIEDRICH, AN RN BSN OCN FROM CHEMOTHERAPY/INFUSION/CSMC RN SUPERVISOR

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN B5.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED FROM THE PHOTO RECEIVED. HOWEVER, WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE REVIEW CANNOT BE PERFORMED AND A PROBABLE CAUSE IS UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, PURPLE CLAMP, LUER LOCK, NON-DEHP TUBING. LEAKING WAS REPORTED WHEN USING THE MICROCLAVE WHILE PUTTING IN AN IV AND ATTACHING THE DEVICE. BLOOD CAME BACK IN ONE INSTANCE AND ONE WAS FLUSHING SALINE. THE PATIENT WAS RECEIVING DOCETAXEL AND HAD DRIPS ON ARM AT CONNECTIONS, THEY USED SOAP AND WATER TO WASH. THEIR USUAL SET UP WAS WITH AN UNSPECIFIED ANGI CATH AND THIS J LOOP CONNECTED TO NON-PVC ALARIS TUBING. THERE WAS ALSO SLIGHT DELAY AS THE NURSE DONNED PPE, SWITCHED OUT JLOOP AND THEN ADMINISTERED REST OF INFUSION. IT WAS STATED THAT THEY COULD NOT FIGURE OUT IF THERE MAY BE A "CRACK" ON THE DEVICE OR JUST PART OF THE PLASTIC THAT IS SUPPOSE TO BE THERE. THERE WAS NO HARM AS A RESULT OF THE COMPLAINT ISSUE.

    Description of Event or Problem · 0

    CORRECTION TO ORIGINAL B5 INFORMATION: BLOOD CAME BACK IN THIS INSTANCE AND SALINE WAS NOT FLUSHING. ALL OTHER ORIGINAL B5 INFORMATION REMAINS CORRECT AS PREVIOUSLY SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847730 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14055600 00887709037281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DOCETAXEL, MFR UNK.| SALINE SOLUTION, MFR UNK.| UNSPECIFIED ANGI CATH, MFR UNK.| UNSPECIFIED NON-PVC IV TUBING/LINE, MFR ALARIS.