BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84

    MDR report key: 16599621 · Received March 23, 2023

    Report

    Report Number
    9617594-2023-00123
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 1, 2023
    Report Date
    November 9, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619068684
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED PARTIAL. LIST #011-46110-29, TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFEST¿ RESERVOIR, 84" RED STRIPE ARTERIAL PRESSURE TUBING AND 2 NEEDLELESS VALVES; LOT #6032802. THE REPORTED COMPLAINT OF PLUNGER TIP SEPARATION IS CONFIRMED ON THE RETURNED SET. DURING VISUAL INSPECTION, THE PLUNGER WAS FOUND DETACHED FROM THE PLUNGER TIP. THE PLUNGER TIP OF THE SAFEST RESERVOIR WAS SEPARATED AND UNABLE TO BE PULLED BACK. THE PROBABLE CAUSE WAS DUE TO THE CLIPS NOT BEING FULLY INSERTED (ENGAGED) INTO THE MATING COMPONENT DURING THE MANUFACTURING PROCESS .THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION IN G1 D9 DEVICE RETURNED TO MANUFACTURER ON 9/14/2023.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2023 AND INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84" RED STRIPE ARTERIAL PRESSURE TUBING AND 2 NEEDLELESS VALVES. THE FOLLOWING ISSUE WAS REPORTED BY THE CUSTOMER, WHEN ASPIRATING WITH THE SYRINGE, THERE WAS NO BACKFLOW OF BLOOD BECAUSE THERE WAS A BROKEN PIECE IN IT. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY. HOWEVER, NO REPORT OF PATIENT HARM AND NO NEED FOR ADDITIONAL MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739995 TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84 TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6032802 00840619068684

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SYRINGE, UNK MFR