BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2232056 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22280
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AN ACTUAL SAMPLE WAS SENT IN FOR AN EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION REVEALED THAT THE BAGS WERE INFLATED WITH AIR AND IT WAS NOTICED THAT AIR WAS LEAKING INTO FLAPS THROUGH THE "LINES" VISIBLE IN THE SEAL HENCE REPORTED PROBLEM WAS CONFIRMED. THOSE "LINES" ARE CREATED DUE TO EXCESSIVE FORMATIONS IN THE MYLAR SHEETING USED DURING THE SEALING PROCESS OF THE BAGS. THE MYLAR SHEETING BELOW THE MOLD IS BEING CHANGE IN EVERY SHIFT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY HAD ONE UNIT OF A 3L OXYGEN BAG IN WHICH IT WAS REPORTED THAT THE UNIT WAS LEAKING INTO THE FLAP. THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, IV KPE BAXTER HEALTHCARE - MALTA 11E31V622

    Patients

    Seq Age Sex Outcome Treatment
    1