BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LF ANGIOMAT ILLUMENA

    MDR report key: 7494098 · Received May 8, 2018

    Report

    Report Number
    7494098
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    February 19, 2018
    Report Date
    April 17, 2018
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY LLC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RISK: THE INJECTOR SYRINGE CRACKED DURING AN ANGIOGRAM OF THE ABDOMINAL AORTA AND STARTING LEAKING. ALSO, A SCREW ON THE INJECTOR SLEEVE WAS NOTED TO BE BENT UPON INSPECTION. THE INJECTOR WAS REMOVED FROM SERVICE. THE INJECTOR SYRINGE INFORMATION IS: LIEBEL-FLARSHEIM ILLUMENA SYRINGE- REFERENCE #: (B)(4), LOT #: C027132U, EXPIRATION DATE- 2/15/2020. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. WE OBTAINED ANOTHER INJECTOR AND COMPLETED THE PROCEDURE. CLINICAL EQUIPMENT HAS THE INJECTOR AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339295 LF ANGIOMAT ILLUMENA INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT LIEBEL-FLARSHEIM COMPANY LLC 900103 C027132U

    Patients

    Seq Age Sex Outcome Treatment
    1