BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 5051406 · Received September 2, 2015

    Report

    Report Number
    1416980-2015-34690
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 25, 2015
    Report Date
    September 16, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LJH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF A COMPANION SAMPLE WAS PROVIDED FOR EVALUATION. PHOTOGRAPHIC INSPECTION DID NOT IDENTIFY ANY DEFECTS OR NON-CONFORMANCES. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UROMATIC ADMINISTRATION SET LEAKED AT ITS CONNECTION POINT WITH A BAG OF SODIUM CHLORIDE (NON-BAXTER PRODUCT). THE REPORTER STATED THAT THE SET DID NOT SEEM TO HOLD ONTO THE BAG WELL. THIS WAS NOTICED DURING PRIMING. THE CUSTOMER REPORTEDLY USED THESE TWO PRODUCTS TOGETHER IN THE PAST REGULARLY WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581130 ACCESS SYSTEM, IRRIGATION, UROLOGICAL LJH BAXTER HEALTHCARE - MALTA 15D01V259

    Patients

    Seq Age Sex Outcome Treatment
    1