BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2152088 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10653
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON (B)(4) 2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED A LEAK NEAR THE INJECTION PORT SEAL. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A 2000ML PVC BAG IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, THE BAG WAS LEAKING NEAR THE INJECTION PORT SEAL. THE CONDITION WAS IDENTIFIED PRIOR TO PATIENT USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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 11A21V233M

    Patients

    Seq Age Sex Outcome Treatment
    1