BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3042930 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00351
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. SAMPLES ARE EXPECTED BUT HAVE NOT YET BEEN RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE LOTS WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MANUFACTURER'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE INFUSION CANNULA DISLODGED FROM THE TROCAR CANNULA DURING VITRECTOMY PROCEDURE. THEY REINSERTED THE INFUSION CANNULA INTO THE TROCAR CANNULA AND THE CASE WAS ABLE TO BE COMPLETED WITHOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE INFUSION CANNULA HAD BEEN REUSED, AND THAT THERE IS A POSSIBILITY THAT THE INFUSION CANNULA CAME FROM ANOTHER MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94722 CUSTOM PAK CONVENIENCE KIT KYG ALCON - IRVINE TECHNOLOGY CENTER CUSTOM PAK 12025029X

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS 800CS| 23 GAUSE ENHANCED ENTRY SYSTEM