BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3900545 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20696
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED. VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED THAT THERE WAS A LEAK IN THE INTERNAL BAG. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3L EMPTY EVA BAG LEAKED. THIS OCCURRED BEFORE USE NEAR THE MEDICATION AND ADMINISTRATION PORTS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377582 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CALI SE13LA3

    Patients

    Seq Age Sex Outcome Treatment
    1