BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIK PAK

    MDR report key: 1773914 · Received July 23, 2010

    Report

    Report Number
    2028159-2010-01302
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    LRO
    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

    A SAMPLE IS BEING RETURNED FOR IN-HOUSE EVALUATION. 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT IMPACT" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "23G INFUSION NEEDLE IN 25GA PAK" (DEVICE MISASSEMBLED DURING MANUFACTURING OR SHIPPING). A CUSTOMER REPORTED THAT A 23 GAUGE INFUSION NEEDLE WAS FOUND IN A 25 GAUGE PACK WHEN OPENED. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIK PAK PIK PAK LRO ALCON - IRVINE TECHNOLOGY CENTER 8065XXXXPP 9033146X

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS 800CS