BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESSURE INJECTABLE TRIPLE LUMEN

    MDR report key: 20522870 · Received October 23, 2024

    Report

    Report Number
    MW5161505
    Event Type
    Other
    Date Received
    October 23, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    PND
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    APN (ADVANCED PRACTICE NURSE) OPENED A TELEFLEX PRESSURE INJECTABLE THREE LUMEN CVC (CENTRAL VENOUS CATHETER) KIT. WHILE OBSERVING THE STERILITY OF THE PACKAGE, APN NOTICED A BROWN PARTICLE IN THE CENTER OF THE STERILITY FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570780 PRESSURE INJECTABLE TRIPLE LUMEN MIDLINE CATHETER PND ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) 33F24D0809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown