BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMO AID ADD-A-LINE

    MDR report key: 1910135 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05287
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED DUE TO CHEMOTHERAPY CONTAMINATION. SINCE THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. IF 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. THIS MDR WAS SUBMITTED ON (B)(4) 2010; HOWEVER, DUE TO A FAILED ACKNOWLEDGEMENT 3, THIS MDR IS BEING RESUBMITTED ON (B)(4) 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A CHEMO AID ADD-A-LINE THAT HAD A LEAK. ACCORDING TO THE REPORT, WHEN SPIKE IS INTRODUCED TO THE VIAFLO BAG THE SPIKE BREAKS AND WHEN CHEMOTHERAPY IS ADDED IN VALVE, IT STARTS LEAKING OR BREAKS. THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 1 OF 10 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO AID ADD-A-LINE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10B03V523M

    Patients

    Seq Age Sex Outcome Treatment
    1