BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF

    MDR report key: 14713748 · Received June 16, 2022

    Report

    Report Number
    9617594-2022-00175
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THE CUSTOMER IDENTIFIED 3 POSSIBLE LOT NUMBERS (PLOTS): 5201049 (EXPIRY DATE 02/01/2024, MFR DATE 03/01/2021). 5254594 (EXPIRY DATE 04/01/2024, MFR DATE 05/01/2021). 5487785 (EXPIRY DATE 07/01/2024, MFR DATE 12/01/2020).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF SEPARATION CAN BE CONFIRMED ON THE RETURNED USED LIST #011-46115-21, TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT; LOT #UNKNOWN. AS RECEIVED, THE STOPCOCK WAS SEPARATED FROM THE BASE OF THE BARREL RESERVOIR. THE AREA OF THE SEPARATION WAS EXAMINED. THERE WAS ADHESIVE OBSERVED ON THE BASE OF THE BARREL RESERVOIR. HOWEVER, THE OBSERVED ADHESIVE WAS TACKY. THE PROBABLE CAUSE OF THE SEPARATION OBSERVED IS DUE TO UV ADHESIVE NOT BEING FULLY CURED DURING THE MANUAL ASSEMBLY PROCESS DURING MANUFACTURING. D9 - DATE RETURNED TO MFG: 7/7/2022. ADDITIONAL ENTRIES CAN BE FOUND IN A5, A6 AND H6 (COMPONENT CODE).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT. IT WAS REPORTED THAT THE SAFESET BECAME LOOSE AND DISCONNECTED BETWEEN THE RESERVOIR AND THE LINE GOING TO THE PATIENT (THE DILUENT SET WAS DISCONNECTED FROM THE TWO WAY VALVE). IT APPEARED THAT THE ADHESIVE HADN¿T STUCK AND ADHESIVE WAS OBSERVED AT THE POINT OF DISCONNECTION. THE SAFESET WAS REPLACED WITH A NEW ONE THAT WAS NOT LOOSE AND DID NOT APPEAR THAT IT WOULD COME APART IN THE SAME AREA. THE NUMBER OF HOURS THE DEVICE WAS USED WAS 0.1. NO MEDICATION WAS BEING USED WITH THE PRODUCT. THERE WAS NO LEAKAGE. ALTHOUGH THERE WAS A DELAY IN THERAPY, THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. THIS CAPTURES THE FIRST OF TWO EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312913 TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEPARIN SODIUM 0.45% SODIUM CHLORIDE, MFR UNK