BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2122179 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07570
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED AND IS AWAITING EVALUATION. WHEN THE EVALUATION RESULTS ARE COMPLETE, A FOLLOW-UP MEDWATCH 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED THE MALE LUER WAS DISCONNECTED FROM THE TUBING. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTIBUTED TO A LACK OF SOLVENT TO BOND THE TWO COMPONENTS. 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 SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERLINK SYSTEM SECONDARY MEDICATION SET IN WHICH THE MALE LUER ADAPTOR DISCONNECTED FROM THE TUBING. 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 - SHERBROOKE ST11B171

    Patients

    Seq Age Sex Outcome Treatment
    1