BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2220980 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20457
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 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). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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). TWO ACTUAL SAMPLES WERE RETURNED TO THE PLANT FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED. FROM THE INVESTIGATION PERFORMED, IT WAS CONCLUDED THAT IN THE CASE OF THESE TWO UNITS, THE WELD WAS NOT PROPERLY PERFORMED DURING MANUFACTURING. THIS WAS DUE TO EXCESSIVE FORMATIONS IN THE MYLAR SHEETING USED DURING THE SEALING PROCESS OF THE BAGS. THE MYLAR SHEETING BELOW THE MOLD IS NOW BEING CHANGE IN EVERY SHIFT. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN UNKNOWN NUMBER OF 6-WAY 3 LITER OXYGEN BARRIER BAGS IN WHICH LEAKS WERE IDENTIFIED. ACCORDING TO THE REPORT, "2/3 OF THE 3L BAGS LEAKED/BURST LAST WEEK IN PATIENTS HOMES." THE CONDITIONS OCCURRED BEFORE USE AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINERS, IV KPE BAXTER HEALTHCARE - MALTA 11E31V621

    Patients

    Seq Age Sex Outcome Treatment
    1