BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2062781 · Received April 19, 2011

    Report

    Report Number
    6000001-2011-02964
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL SAMPLE WAS RETURNED TO THE PLANT FOR EVALUATION. THE REPORTED CONDITION OF THE MALE LUER IS "FATTER THAN NORMAL," CAUSING NO FLOW WAS CONFIRMED. FLOW WAS OBTAINED DURING TESTING BUT THE MALE LUER FAILED ISO GAUGING TESTING. AN ASSIGNABLE ROOT CAUSE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN INTERLINK SYSTEM BASIC SOLUTION SET IN WHICH THE SET FLOWS VERY SLOWLY. ACCORDING TO THE REPORT, THIS SET WAS CONNECTED TO A B BRAUN SAFESITE VALVE, AND IT APPEARS AS IF THE MALE LUER IS "FATTER THAN NORMAL" AND THE REPORTER COULD NOT ACTUATE THE BLUE DEPRESSOR OF THE B BRAUN SAFESITE VALVE ENOUGH TO PRODUCE GOOD FLOW. THE FACILITY THEN SWITCHED TO USING A BASIC SET (PRODUCT CODE: 1C8109) AND THEY HAVE NOT HAD ANY PROBLEMS SINCE. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR11A04064

    Patients

    Seq Age Sex Outcome Treatment
    1 B BRAUN SAFESITE VALVE