BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMO AID SET ADD-A-LINE

    MDR report key: 1994068 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01080
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE WAS SUBMITTED FOR EVALUATION. VISUAL INSPECTION REVEALED NO NON-CONFORMANCES. A LUER SYRINGE WAS ATTACHED TO THE Y SITE AND FLUID WAS INJECTED. NO LEAKS OR OTHER ABNORMALITIES WERE REVEALED. THE SET WAS THEN LEAK TESTED UNDER WATER AND NO LEAKS WERE REVEALED. THEREFORE THE REPORTED PROBLEM HAS NOT BEEN CONFIRMED. IT IS UNKNOWN WHAT CAUSED THIS REPORTED CONDITION. 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 SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CHEMO AID SET THAT LEAKED AFTER ADDING CYTOSTATIC DRUGS VIA THE VALVE. IT SEEMED TO THE CUSTOMER THAT THE VALVE BLOCKS AND DOESN'T FUNCTION AS AN ANTIREFLUX. THIS OCCURRED IN THE LAMINAR FLOW CABINET. A NURSE HAD TO CLEAN UP THE LEAKED SOLUTION. 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 CHEMO AID SET ADD-A-LINE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10B03V521M

    Patients

    Seq Age Sex Outcome Treatment
    1 CYTOSTATIC DRUG