BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONVENTED SPIKE WITH CLEARLINK

    MDR report key: 1994077 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01077
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 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). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 02/09/2011. A COMPANION SAMPLE WAS SUBMITTED FOR EVALUATION FOR THE REPORTED CONDITION OF A BLOCKED CLEARLINK VALVE. THE SET WAS TESTED FOR BLOCKAGE USING A LUER-LOCKING SYRINGE. THIS ANALYSIS SHOWED THE CLEARLINK VALVE WAS BLOCKED AS DESCRIBED BY THE CUSTOMER. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO A RAW MATERIAL ISSUE (SUPPLIER ERROR/MOULDING ISSUE). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION 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. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A NON-VENTED SPIKE WITH CLEARLINK SOLUTION ADMINISTRATION SET THAT WAS INVOLVED IN A NO FLOW/RESTRICTED FLOW. ACCORDING TO THE REPORT, THE NURSE STATED THE CLEARLINK VALVE IS BLOCKED BECAUSE WHEN THE OPERATOR TRIED TO INJECT OR SUCK OUT A SOLUTION THROUGH IT INTO A BAG USING A LUER-LOCK SYRINGE, THERE WAS A RESISTANCE AND THE VALVE SEEMS TO BE CLOSED. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING USE; HOWEVER, THERE WAS NO PATIENT INVOLVEMENT. THERE WAS 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 NONVENTED SPIKE WITH CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10G03V034M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN LUER LOCKING SYRINGE