BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 3030972 · Received March 28, 2013

    Report

    Report Number
    1119279-2013-00091
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    February 26, 2013
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO B+L. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TECH SCREWED THE CANNULA ONTO THE LUER LOCK AND USED IT TO FILL THE INSERTER WITH VISCOELASTIC. SHE SET THE SYRINGE DOWN ON A TRAY AND WHEN SHE RETURNED TO THE TRAY THE CANNULA AND LUER LOCK HAD DETACHED FROM THE SYRINGE. THERE WAS NO PT CONTACT OR INJURY REPORTED. A BACKUP AMVISC PLUS WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127582 AMVISC PLUS LZP LIFECORE BIOMEDICAL, LLC 60081L 024257R

    Patients

    Seq Age Sex Outcome Treatment
    1