BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 FASTURN SYRINGE KIT W/QFT

    MDR report key: 2980833 · Received February 21, 2013

    Report

    Report Number
    2520313-2013-00009
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO HAVE THE PRODUCT RETURNED TO (B)(4) AND I FOR PRODUCT ANALYSIS; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE FASTURN AND PUSH-N-TURN SYRINGES INSTRUCTIONS FOR USE STATES: VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE. BASED ON THE LIMITED AMOUNT OF INFORMATION REPORTED, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE ALLEGED PARTICULATE. IN THE EVENT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: AFTER LOADING THE SYRINGE WITH CONTRAST A FLOATING BLACK THREAD LIKE OBJECT WAS NOTED IN THE SYRINGE. VISUAL INSPECTION OF THE TUBING PRIOR TO USE PREVENTED THE SYRINGE FROM BEING USED FOR A PATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75472 150 FASTURN SYRINGE KIT W/QFT ANGIOGRAPHIC SYRINGE KIT DXT MEDRAD 3026767 132465

    Patients

    Seq Age Sex Outcome Treatment
    1 MARK V PROVIS ANGIOGRAPHIC INJECTOR