BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,

    MDR report key: 12068064 · Received June 25, 2021

    Report

    Report Number
    9617594-2021-00183
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 6, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619068615
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST# 886-42584-05, TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH DEVICE, MACRODRIP. LOT# 4960635. THE REPORTED COMPLAINT OF TUBING DISCONNECTION/SEPARATION WAS CONFIRMED ON THE RETURNED SET. AN IMAGE WAS PROVIDED BY THE CUSTOMER SHOWING THE AREA OF THE DEFECT. DURING VISUAL INSPECTION, THE 48.5" PRESSURE TUBING WAS FOUND SEPARATED FROM THE FEMALE LUER. THE PRESSURE TUBING WAS FOUND TACKY AT THE BOND SITE. THE SEPARATION OF THE BOND WAS DUE TO THE PRESSURE TUBING BEING TACKY. THE PROBABLE CAUSE OF THE PRESSURE TUBING BEING TACKY IS DUE TO THE SOLVENT ON THE TUBING NOT BEING FULLY CURED DURING ASSEMBLY PROCESS. A LOT REVIEW WAS PERFORMED AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(6) 2021 FOR EVALUATION. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT THAT THE CUSTOMER REPORTED THE TUBING DETACHED FROM THE 3-WAY STOPCOCK BELOW THE TRANSDUCER DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966897 TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE, TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4960635 00840619068615

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE, MFR UNK| NORMAL SALINE, MFR UNK