BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIASSIST

    MDR report key: 7479405 · Received May 2, 2018

    Report

    Report Number
    7479405
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    December 12, 2017
    Report Date
    April 26, 2018
    Manufacturer
    ANGIOADVANCEMENTS, LLC
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE USING CO2, IT WAS NOTED THAT ONE OF THE SYRINGES BROKE OFF IN THE 3-WAY STOPCOCK, ALLOWING AIR TO GET IN. IT WAS CORRECTED RIGHT AWAY BEFORE IT WAS USED ON THE PT. A NEW CO2 SET-UP WAS OBTAINED AND USED. THIS WAS AN EQUIPMENT ISSUE. THE TIP OF THE SYRINGE ACTUALLY BROKE OFF INTO THE STOP COCK. ONCE THIS WAS DISCOVERED, IT WAS REPLACED WITH A NEW ONE AND THE CASE CONTINUED WITH NO FURTHER PROBLEMS. NO INJURY TO PATIENT. DEVICE WAS NOT SEQUESTERED AND IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322745 ANGIASSIST TUBING, PRESSURE AND ACCESSORIES BYX ANGIOADVANCEMENTS, LLC 7108

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR