BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANISHPOINT

    MDR report key: 6538067 · Received April 28, 2017

    Report

    Report Number
    MW5069481
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    April 28, 2017
    Report Date
    April 28, 2017
    Manufacturer
    RETRACTABLE TECHNOLOGIES
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A VANISHPOINT SYRINGE WAS NOTED TO NOT HAVE ANY MARKINGS ON IT FOR MEASUREMENT OF DRUG. THE SYRINGE WAS A 3ML 21G X 1 1/2 INCH SYRINGE WITH THE LOT #A160202. THE SYRINGE IS MADE BY RETRACTABLE TECHNOLOGIES. NO OTHER SYRINGES IN THE BOX OF (B)(4) WERE FOUND TO HAVE ISSUE. THE SYRINGE WAS NOT USED IN PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313484 VANISHPOINT VANISHPOINT MEG RETRACTABLE TECHNOLOGIES 10361 A160202

    Patients

    Seq Age Sex Outcome Treatment
    1