BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2830021 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04926
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS DEVICE IS 510(K) EXEMPT - CLASS II (SPECIAL CONTROLS). THEREFORE, A 510K NUMBER WILL NOT BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED, AS A SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION AND THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF A VENTED SPIKE ADAPTER THAT WAS ALLEGED TO HAVE DISCONNECTED FROM AN UNKNOWN SOLUTION BOTTLE. THE SPIKE ADAPTER WAS BEING UTILIZED ON AN ADMINISTRATION SET (PRODUCT CODE 2H8537) TO ALLOW THE SET TO VENT. THIS CONDITION WAS REPORTED TO HAVE OCCURRED DURING SET-UP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1