BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2233660 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22563
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A SAMPLE WAS EVALUATED AND A LEAK TEST WAS PERFORMED. DURING THE TEST IT WAS CONFIRMED THAT THERE WAS A LEAK ON THE CONNECTION SEALING IN THE SAMPLE. THE CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EVA BAG IN WHICH WHEN THE BAG WAS FILLED, IT WAS REALIZED THAT DURING THE INTEGRITY TEST, THE BAGS PRESENTED LEAKAGE. THE LOCATION OF THE LEAK IS IN THE INJECTION SITE. THIS WAS NOTICED BEFORE USAGE; THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - SAO PAULO PE33S0

    Patients

    Seq Age Sex Outcome Treatment
    1