BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 1940478 · Received December 17, 2010

    Report

    Report Number
    1644019-2010-00102
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ALCON-HOUSTON
    Product Code
    LRO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 12/17/2010. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE STERI STRIPS DID NOT HAVE ADEQUATE ADHESION, WHICH ALLOWED THE INFUSION TUBING TO KINK AND THE CANNULA TO SHIFT. ADDITIONALLY, THE SURGEON REPORTED THAT THE SHIFT OF THE CANNULA WAS DETECTED PRIOR TO BEGINNING THE VITRECTOMY AND THAT THE PATIENT DID NOT SUFFER ANY HARM FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT LRO ALCON-HOUSTON CUSTOM PAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention