BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMVISC PLUS

    MDR report key: 2860154 · Received November 21, 2012

    Report

    Report Number
    1119279-2012-00287
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    LIFECORE BIOMEDICAL, LLC
    Product Code
    LZP
    PMA / PMN Number
    P810025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. THE PRODUCT HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. RESULTS WILL BE SUBMITTED TO THE FDA IN SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF AMVISC PLUS FOR USE, THE VISCOELASTIC BEGAN TO LEAK AT THE JUNCTION OF THE SYRINGE AND LUER LOCK. THE CANNULA AND LUER LOCK DETACHED FROM THE SYRINGE AS THE SCRUB NURSE CONTINUED TO PRESS DOWN ON THE PLUNGER. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMVISC PLUS LZP, AID, SURGICAL VISCOELASTIC LZP LIFECORE BIOMEDICAL, LLC 60081L 024028

    Patients

    Seq Age Sex Outcome Treatment
    1