BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2220570 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20359
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED AT THE PLANT FOR EVALUATION. THE SAMPLE WAS TESTED FOR BLOCKAGE AND LEAKAGE AT 0.56BAR, BOTH TESTS WERE CONFORMING, NO ISSUE WAS OBSERVED. HENCE THE DEFECT (DAMAGED SET: MALFORMED) DOES NOT AFFECT THE FUNCTIONALITY OF THE SET. IN THE MEAN TIME THE SET SHOWED WHITE TRACES; THEREFORE THE REPORTED CONDITION WILL BE CONFIRMED, WITH AN UNIDENTIFIED CAUSE. BATCH FILE REVIEW DID NOT REVEAL ANY ISSUES RELATED TO THIS COMPLAINT AND HAS PASSED ALL STATISTICAL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. THE SAMPLING AND TEST RESULTS CONFIRM THAT THE BATCHES COMPLIED WITH THE REQUIRED QUALITY CHARACTERISTICS AS DEFINED IN THE PROCEDURE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN INTERLINK SET, IN WHICH THERE IS PLASTIC AROUND THE INJECTION PORT DISCOVERED BEFORE USAGE. 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 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 08F05V726

    Patients

    Seq Age Sex Outcome Treatment
    1