BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2921053 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01311
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    August 17, 2012
    Report Date
    December 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WASN?T CONFIRMED DURING EVALUATION. ACTUAL DEVICE WASN?T AVAILABLE FOR EVALUATION; HOWEVER, A PHOTO WAS AVAILABLE FOR VISUAL INSPECTION. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION. NO OTHER TEST WAS PERFORMED. ADDITIONAL INFORMATION: A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A BURETROL ADMINISTRATION SET IN WHICH THE TUBING WAS SPLIT. THE REPORTED CONDITION OCCURRED DURING SERUM PREPARATION. 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
    25920 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE3781

    Patients

    Seq Age Sex Outcome Treatment
    1