BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2231183 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22044
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 8, 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). BATCH FILE REVIEW DID NOT REVEAL ANY ISSUES RELATED TO THIS COMPLAINT . AN ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. THE BAG WAS RECEIVED FILLED WITH SOLUTION. THE BAG WAS HUNG ON A HANGER AND LEFT HANGING FOR 24 HOURS. THERE WERE NO LEAKS NOTICED. HOWEVER, VISUAL INSPECTION REVEALED THAT SOLUTION WAS LEAKING OUT AT A VERY SMALL LEAK RATE BETWEEN ONE OF THE BAG PORTS AND THE BAG. THE LEAK WAS ONLY NOTICED THROUGH CLOSE VISUAL EXAMINATION TO THE PORTS AND BY TRYING TO WIPE WITH A TISSUE AROUND THE PORT. THEREFORE, THE REPORTED PROBLEM WAS CONFIRMED. FURTHER INVESTIGATIONS WITH THE PRODUCTION MANAGER IN CHARGE OF THE FABRICATION OF THE SET MENTIONED THAT THE ESTABLISHED ROOT CAUSE WAS DUE TO AN IMPROPER SEALING.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A 4 LITER OXYGEN BARRIER BAG IN WHICH LEAKING OCCURRED DURING SETUP. 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 ACCESS CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 11D30V188

    Patients

    Seq Age Sex Outcome Treatment
    1