BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4925876 · Received July 20, 2015

    Report

    Report Number
    1416980-2015-29506
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY LEAK OR OTHER ISSUES. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURETROL ADMINISTRATION SET ¿LEAKED THROUGH THE RUBBER WHERE THE MEDICATION IS ADDED.¿ THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469393 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SAO PAULO PE52W4

    Patients

    Seq Age Sex Outcome Treatment
    1