BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DIPOSABLE

    MDR report key: 3133242 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13579
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    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. EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS NOT RECEIVED. HOWEVER, ONE UNUSED UNIT WAS RECEIVED FOR EVALUATION. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION. THE REPORTED CONDITION WAS NOT CONFIRMED. THE UNIT WAS WORKING WITHIN SPECIFICATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE, BUT HAS NOT BEEN RECEIVED AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND ON THE PORT OF A GAMMA STERILIZED EMPTY INTRAVIA CONTAINER. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234737 IVT DIPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13B14101

    Patients

    Seq Age Sex Outcome Treatment
    1