BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWG+ARD BLUE PSI KIT CATH GARD FOR USE WITH 7.5 -8 FR CATHETERS

    MDR report key: 18826248 · Received March 1, 2024

    Report

    Report Number
    MW5152259
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 15, 2024
    Report Date
    February 28, 2024
    Manufacturer
    TELEFLEX / TELEFLEX LLC (NADC)
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STAFF REPORTED THAT THE INDUCER TO THE ARROW G+ARD BLUE PSI KIT CATH GARD HAD LOOKED DIRTY. THE INDUCER HAD A FILM ON IT. THE PRODUCT WAS NOT INSERTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881879 ARROWG+ARD BLUE PSI KIT CATH GARD FOR USE WITH 7.5 -8 FR CATHETERS INTRODUCER, CATHETER DYB TELEFLEX / TELEFLEX LLC (NADC) 33F23F0239

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Other