BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2110715 · Received June 1, 2011

    Report

    Report Number
    6000001-2011-06925
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL UNIT ENCLOSED IN A PLASTIC BAG WAS RECEIVED AT THE PLANT FOR EVALUATION. THE UNIT WAS VISUALLY INSPECTED TO CONFIRM THAT THE CLEARLINK WAS NOT WELL SCREWED TO THE SPIKE; HENCE THE REPORTED INCIDENT BY THE CUSTOMER WAS CONFIRMED DUE TO AN UNIDENTIFIED CAUSE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT.

    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 (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

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEARLINK SET IN WHICH UPON SPIKING THE SET INTO AN UNKNOWN CHEMOTHERAPY BAG THERE IS A LEAK AT THE SPIKE. THIS CONDITION OCCURRED DURING SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10L06V729M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPEUTIC DRUG