BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 1951304 · Received December 14, 2010

    Report

    Report Number
    2648035-2010-00234
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNSEALED TRAY WAS RETURNED TO THE MANUFACTURER ALONG WITH FIVE SEALED TRAYS FOR EVALUATION. THE TRAY LID WAS NOT RETURNED HOWEVER A PHOTO OF THE LID AND TRAY WAS PROVIDED. VISUAL INSPECTION OF THE PHOTO CONFIRMED THAT THE TRAY LID WAS PEELED AND FOLDED BACK ABOUT 2 INCHES FROM THE CORNER OF THE TRAY EXPOSING THE CONTENTS OF THE TRAY. VISUAL INSPECTION CONDUCTED ON THE UNSEALED TRAY REVEALED THAT THERE WAS EVIDENCE OF ADEQUATE SEALANT MATERIAL ALONG THE ENTIRE EDGES OF THE TRAY. THE FIVE SEALED TRAYS WERE EXAMINED AND THE TRAYS WERE FOUND TO HAVE PROPER SEALS. THE CAUSE OF THE UNSEALED TRAY WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE SEALING AND PACKAGING OPERATIONS WAS CONDUCTED AND NO ISSUES WERE FOUND WITH THESE PROCESSES AND WITH THE EQUIPMENT WHICH COULD LEAD TO INADEQUATELY SEALED TRAYS. UNABLE TO DETERMINE CAUSE OF THE TRAY NOT BEING COMPLETELY SEALED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN ITALY REPORTED THAT DURING PRODUCT INSPECTION ONE PHACO TUBING PACK WAS OBSERVED TO HAVE A PARTIALLY UNSEALED TRAY LID. THE LID WAS NOTED TO BE PEELED BACK FROM ONE CORNER. AN UNSEALED TRAY CAN COMPROMISE STERILITY THEREFORE THE PRODUCT WAS RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE PACK, DISPOSABLE TUBING HQC ABBOTT MEDICAL OPTICS OPO71

    Patients

    Seq Age Sex Outcome Treatment
    1