BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1841762 · Received September 22, 2010

    Report

    Report Number
    6000001-2010-03468
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE TO THE PLANT FOR EVALUATION. THE VISUAL INSPECTION REVEALED A HOLE BETWEEN THE INJECTION PORT AND BAG. THE BATCH RECORDS WERE REVIEWED AND ALL RELEASE CRITERIA WAS WITHIN SPECIFICATION. BAXTER HAS RECEIVED SIMILAR REPORTS. THE BAGS USED ON THIS CODE ARE PROVIDED BY AN INTERNAL SUPPLIER. A CAPA HAS BEEN OPENED (LES-CAPA-(B)(4)) TO INVESTIGATE THIS ISSUE AND DETERMINE ROOT CAUSE. 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

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT THE AREA BETWEEN THE INJECTION PORT AND BAG CRACKED ON THE MULTILAYER BAG SET. IT IS UNKNOWN IF THIS CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10A06V195

    Patients

    Seq Age Sex Outcome Treatment
    1