BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE

    MDR report key: 21637002 · Received March 18, 2025

    Report

    Report Number
    9617594-2025-00502
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    January 2, 2025
    Report Date
    March 18, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - DATE OF BIRTH - THE PATIENTS AGE WAS USED TO APPROXIMATE THE DATE OF BIRTH AS (B)(6) 2019. D4 AND H4 THE MATERIAL#, LOT#, UDI EXPIRATION DATE, AND MANUFACTURE DATE ARE UNKNOWN. THE DEVICE WAS NOT SPECIFIED, AND THE 510K WAS ASSUMED TO BE K061573. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT OF SYRINGE WAS BROKEN IS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE PLUNGER WAS FOUND DETACHED FROM THE PLUNGER TIP. THE PLUNGER TIP OF THE SAFESET RESERVOIR WAS SEPARATED AND UNABLE TO BE PULLED BACK. THE PROBABLE CAUSE OF THE DETACHED PLUNGER TIP FROM THE PLUNGER IS DUE TO THE CLIPS NOT BEING FULLY INSERTED OR ENGAGED INTO THE MATING COMPONENT DURING THE MANUFACTURING PROCESS IN ENSENADA.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE THAT EXPERIENCED A BROKEN PLUNGER. THE REPORTER STATED THAT PATIENT'S ART LINE FLUSHED FINE BUT WHEN THIS RN WENT TO DRAW BACK ON THE CLOSED SYSTEM, THE PLUNGER ON THE SYRINGE WAS BROKEN. IT WAS NOT CONNECTED TO THE STOPPER IN THE SYRINGE. THE PATIENT INVOLVED WAS 6.14 YEARS OLD AND MALE. THE AFFECTED AREA OR UNIT LOCATION WAS H2B. THE EVENT DATE OCCURRED ON (B)(6) 2025 AND WAS IN USE FOR PATIENT CARE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306355 AN UNSPECIFIED CLOSED SYSTEM ART LINE SYRINGE TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown