BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2922126 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01375
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K090096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE VERIFIED PRESENCE OF PARTICULATE MATTER IN THE FLUID PATH. THE CAUSE OF THE PARTICULATE MATTER WAS DETERMINED TO BE A MANUFACTURING ISSUE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHARMACIST OF A FACILITY REPORTED TO BAXTER (B)(4) THAT AN ALL-IN-ONE EMPTY CONTAINER, WITH CONNECTOR (500ML), WAS FOUND WITH UNKNOWN PARTICLES INSIDE IT. THIS WAS OBSERVED BY THE PHARMACIST, PRIOR TO PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28235 IVT DISPOSABLE SET, I.V. FLUID TRANSFER KPE BAXTER HEALTHCARE - AIBONITO UR12C16089

    Patients

    Seq Age Sex Outcome Treatment
    1