BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEA

    MDR report key: 19897673 · Received August 2, 2024

    Report

    Report Number
    9617594-2024-01051
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 2, 2024
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE LOT NUMBER IS UNKNOWN A POSSIBLE LOT NUMBER IS 13959618: MANUFACTURING DATE: 04/01/2024. EXPIRATION DATE: 04/01/2029. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A FEW PHOTOS WERE SHARED BY THE CUSTOMER, WHERE AN ICU MEDICAL SET #12514-01 AND UNKNOWN BD DEVICES ARE OBSERVED, BOTH ARE ON A SEALED PACKAGE IN ADDITIONAL PHOTO A SEALED ITEM #12512-01, MICROCLAVE IS OBSERVED AS WELL. HOWEVER, NO DAMAGE, ANOMALIES OR ISSUES ARE OBSERVED. THE COMPLAINT OF LEAKS ON ITEM 12514-01 CANNOT BE CONFIRMED. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. THE LOT REVIEW COULDN'T BE PERFORMED DUE TO THE LOT NUMBER FOR THIS COMPLAINT WAS UNKNOWN.

    Description of Event or Problem · 0

    AN EVENT INVOLVING A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER EXPERIENCED LEAKAGE DURING PATIENT USE. IT WAS REPORTED THAT THERE WERE LEAKING INTRAVENOUS (IV) TUBINGS DURING A COMPUTED TOMOGRAPHY (CT) SCAN. THE REPORTED ISSUE INVOLVED DIFFICULTY IN CONNECTING OR TIGHTENING THE CONNECTORS OF THE DEVICE, WHICH RESULTED IN LEAKING FROM THE IVS. EVIDENCE OF LEAKS WAS OBSERVED BENEATH THE TAGADERM STICKER USED TO COVER THE IV AND CONNECTOR. IT WAS REPORTED THAT THERE WERE LEAKING IVS DURING POWER INJECTION. IN CT, TECHS TEST THE IV BY PUSHING 10CC OF SALINE BY HAND AND POWER INJECTING A SMALL AMOUNT OF SALINE BEFORE PROCEEDING WITH THE CONTRAST/CT SCAN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037511 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEA SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSI| NORMAL SALINE, MFR UNK