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: 18617735 · Received January 31, 2024

    Report

    Report Number
    9617594-2024-00078
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, HOWEVER, INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 0

    RECEIVED TWO USED LIST #12514-01, 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER; LOT #13838870 - NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED. ALSO RECEIVED ONE USED LIST #UNKNOWN, BAXTER ONE-LINK NEEDLE-FREE IV CONNECTOR; LOT #UR22D29093. NON ICU PRODUCT CONNECTOR. ALSO RECEIVED ONE USED USED. LIST #UNKNOWN, DR. (B)(6) NALOXONE HYDROCHLORIDE INJECTION, USP 2MG/2ML SINGLE DOSE SYRINGE; LOT #K230695. ALSO RECEIVED ONE NEW LIST #UNKNOWN, AUROMEDICS NALOXONE HYDROCHLORIDE INJECTION, USP 2MG PER 2 ML SINGLE-DOSE DISPOSABLE PREFILLED SYRINGE; LOT #3NX23006. FOUND A BROKEN MICROCLAVE TIP IN SYRINGE. THE BROKEN MICROCLAVE WAS NOT RETURNED. THE 2 LIST #12514-01 WERE PRIMED AND LEAK TESTED. BOTH SETS PRIMED WITHOUT ANY ISSUES. NO LEAKS WERE OBSERVED. MEASURED THE INTERNAL DIAMETER OF THE RECEIVED SYRINGES. DR REDDY: 0.045" AUROMEDICS COULDN'T BE MEASURED DUE TO BROKEN TIP. THE REPORTED COMPLAINT OF BREAKING COULD BE CONFIRMED. A SYRINGE WAS RETURNED WITH A BROKEN MICROCLAVE TIP. THE PROBABLE CAUSE IS FROM THE USE OF AN INCOMPATIBLE MATING DEVICE. THE DIRECTIONS FOR USE STATES: THE CLAVE CONNECTOR IS COMPATIBLE WITH LUERS WITH AN INTERNAL DIAMETER BETWEEN 0.062¿ AND 0.110." THE LOT HISTORY OF THE PROVIDED PACKAGING WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEAR, PURPLE CLAMP, ROTATING LUER. THE CUSTOMER REPORTED THAT THE DEVICE WAS BREAKING AND MEDICATION CANNOT BE PUSHED THROUGH. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385540 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