BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4110947 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32797
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    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). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING DETERMINED THAT THE DEVICE LEAKED BETWEEN THE WELDING OF ADDITIVE PORTS TO THE BAG. CLOSER VISUAL EXAMINATION TO THE LEAK AREA REVEALED THAT THE BAG HAD A LACK OF WELDING. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. THE PRODUCTION PROCEDURE WAS UPDATED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMPOUNDING BAG LEAKED FROM ¿PAST THE PORT TUBING OF THE ADDITIVE PORT¿ WHICH WAS NOT IN USE AT THE TIME OF THE LEAK. THIS OCCURRED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591922 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 14A01V171

    Patients

    Seq Age Sex Outcome Treatment
    1