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: 19893674 · Received August 2, 2024

    Report

    Report Number
    9617594-2024-01008
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 4, 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

    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.

    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. POSSIBLE LOT NUMBER: 13959618, MFR DATE: 4/1/2024, EXP DATE: 4/1/2029.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE IT WAS REPORTED THAT THERE WAS LEAKING IN IV'S. THERE WERE 8 INCIDENCES OCCURRED IN THE INPATIENT DEPARTMENT OF THE FACILITY WITHIN THE PAST TWO WEEKS. THE REPORTED ISSUE INVOLVED DIFFICULTY IN CONNECTING OR TIGHTENING THE CONNECTORS OF THE DEVICE, WHICH RESULTED IN LEAKING FROM THE IVS IT WAS USED WITH. EVIDENCE OF LEAKS WAS OBSERVED BENEATH THE TEGADERM STICKER USED TO COVER THE IV AND CONNECTOR. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO DELAY IN THERAPY OR HUMAN HARM REPORTED. THIS EVENT OCCURRED IN THE 8CCP. THIS CAPTURES 7 OF 8 OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958843 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 INSYTE AUTOGUARD, BD MEDICAL.| NEUTRAL CONNECTOR, ICU MEDICAL.