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: 21334718 · Received February 7, 2025

    Report

    Report Number
    9617594-2025-00238
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 7, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709068193
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - THIS COMPLAINT WAS RECEIVED THROUGH: (B)(6). INVESTIGATION SUMMARY RECEIVED ONE (1) USED LIST# A1129 SMALLBORE PRESSURE INFUSION EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR (PURPLE RING), ROTATING LUER. AS RECEIVED, THE A CRACK WAS VISIBLE DOWN THE SIDE OF THE FEMALE LUER AS IT WAS ATTACHED TO THE MICROCLAVE. THE SET WAS TESTED AS PER SPECIFICATION AND LEAKING FROM THE CRACK ON THE FEMALE LUER WAS CONFIRMED. A DHR LOT AND RELEVANT COMMODITIES WERE REVIEWED, THE FOLLOWING DISCREPANCY WAS IDENTIFIED: EXCEPTION TYPE: NCMR LOT#: 13873977, 13645808, 5775140 DISCREPANCY: "DURING VISUALS INSPECTION ON MOLDING QA FOUND BROKEN INSERT ON CAVITY A54. AFTER BRACKETING TOTES 23-28 WERE AFFECTED." " A2 QUALITY FOUND CUTS IN SILICONE ON INNER DIAMETER OF PLUG IN START UP OF LOT # 13667981" "DURING ROUTINE MOLDING VISUAL INSPECTION, MQA INSPECTOR FOUND LOOSE DEBRIS. BAGS 4-8 ARE AFFECTED. BAGS 1-3 ARE ALSO AFFECTED." THE COMPLAINT OF LEAKING AND BREAKAGE CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE CRACK IS UNKNOWN.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, NANOCLAVE® T-CONNECTOR (PURPLE RING), ROTATING LUER THAT EXPERIENCED BREAKAGE AND LEAKAGE. THIS IS REPORT 2 OF 2. IT WAS STATED IN THE REPORT THAT ONCE OF MY CUSTOMERS IS EXPERIENCING LEAKING AND INJECTION PORTS ARE BREAKING; DR. STATED THAT THE T-CONNECTOR THE PATIENT CAME WITH FROM THE CICU WAS BROKEN. THE REPLACEMENT ALSO BROKE, THIS TIME IT¿S THE INJECTION PORT CLOSEST TO THE HUB CONNECTED TO THE PIV THAT BROKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT WERE HARMED BUT THERE WAS A DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880339 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. 14049374 00887709068193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown