BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV MONITORING SPIKE KIT W/03 ML SQUEEZE FLUSH DEVICE AND NEEDLELESS VA

    MDR report key: 11897823 · Received May 27, 2021

    Report

    Report Number
    9617594-2021-00170
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619091897
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED FROM AN UNKNOWN FACILITY THAT THE TUBE OF A TRANSPAC IV MONITORING SPIKE KIT WITH LIST NUMBER WAS DISCONNECTED AS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RETURNED FOR EVALUATION AND DURING TESTING THE REPORTED CONDITION WAS CONFIRMED. ONE USED LIST# 081-46114-89, LOT# 4895752 WAS RETURNED FOR EVALUATION. AN IMAGE WAS PROVIDED BY CUSTOMER SHOWING THE AREA OF DISCONNECTION. DURING VISUAL INSPECTION, THE 24" TUBING WAS FOUND SEPARATED FROM THE FEMALE LUER. THE TUBING WAS FOUND TACKY. THE TIP OF THE TUBING HAD UV ADHESIVE. HOWEVER, PER THE CONFIGURATION, THE TUBING AND FEMALE LUER WAS SUPPOSED TO BE A SOLVENT BOND AND NOT A UV ADHESIVE BOND. THE SEPARATION HAD OCCURRED DUE TO THE TUBING WAS NOT FULLY CURED DURING ASSEMBLY PROCESS AT ENSENADA. THE PROBABLE CAUSE OF THE INCORRECT BOND HAD OCCURRED DUE TO AN ERROR DURING ASSEMBLY PROCESS. A DEVICE HISTORY REVIEW OF LOT# 4895752 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789424 TRANSPAC IV MONITORING SPIKE KIT W/03 ML SQUEEZE FLUSH DEVICE AND NEEDLELESS VA TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4895752 00840619091897

    Patients

    Seq Age Sex Outcome Treatment
    1