BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2832182 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05102
    Event Type
    Malfunction
    Date Received
    November 14, 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
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:AN UNUSED SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. PARTICULATE MATTER (PM) WAS FOUND TO BE OUTSIDE THE FLUID PATH OF THE SAMPLE. NO FUNCTIONAL TESTS WERE PERFORMED. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION: THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION, IT WAS FOUND THAT THE PROBLEM WAS NOT CONFIRMED FOR THE ORIGINAL REPORTED CONDITION OF PLASTIC PARTICLES DETECTED IN DIFFERENT COMPOUNDED BAGS. THE PLASTIC PARTICLES WERE NOT DETECTED IN THE DIFFERENT COMPOUNDED BAGS. HOWEVER, INK FROM THE LABEL PRINT WAS FOUND OUTSIDE THE FLUID PATH. THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT ON (B)(4) 2012 FROM A CUSTOMER REGARDING A AUTOMIX 3+3 COMPOUNDER LEAD TRANSFER SET IN WHICH PLASTIC PARTICLES WERE DETECTED IN DIFFERENT COMPOUNDED BAGS. THE PROCESS STEP IS DURING STORAGE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION 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 R11G12205

    Patients

    Seq Age Sex Outcome Treatment
    1