BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI

    MDR report key: 12607618 · Received October 11, 2021

    Report

    Report Number
    9617594-2021-00275
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 20, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619057695
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED LIST #011-46106-74, TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBING (152CM); LOT #5142233 WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, THE PVC TUBING WAS RECEIVED SEPARATED FROM THE WINGED MALE LUER. WHEN THE TUBING POCKET WAS MICROSCOPICALLY EXAMINED, INSUFFICIENT SOLVENT COVERAGE WAS OBSERVED ON THE TUBING. THE PROBABLE CAUSE OF THE DISCONNECTION HAD OCCURRED DUE TO INSUFFICIENT SOLVENT APPLIED ON THE PVC TUBING DURING ASSEMBLY PROCESS. LOT HISTORY REVIEW WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE, AND INVOLVED A TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBING (152CM) IN WHICH THE CUSTOMER REPORTED THAT THE TUBING COMES UNDONE AT THE FITTING. THE INCIDENT OCCURRED DURING PRIMING AND THERE WAS NO PATIENT INVOLVEMENT. NO MEDICATION WAS BEING ADMINISTERED; THE DEVICE WAS PRIMED WITH NACL. THE CUSTOMER SWITCHED OUT THE DEVICE AND NO FURTHER ISSUES WERE ENCOUNTERED. THERE WAS NO HARM REPORTED AS CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501064 TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5142233 00840619057695

    Patients

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