BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3031357 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08129
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    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). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF AN UNUSED SAMPLE WAS PERFORMED AND VERIFIED PRESENCE OF PARTICULATE MATTER INSIDE THE FLUID PATH. THE CAUSE OF THIS ISSUE WAS RELATED TO A MANUFACTURING PROCESS ISSUE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALL-IN-ONE EMPTY CONTAINER, WITH CONNECTOR, HAD AN UNKNOWN AMOUNT OF PARTICLES PRESENT INSIDE THE DEVICE. THIS EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY/ADVERSE EVENTS, NOR 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
    134144 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR12E25077

    Patients

    Seq Age Sex Outcome Treatment
    1