BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2990139 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05282
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED. VISUAL INSPECTION OF THE DEVICE NOTED NO OBVIOUS DEFECTS ON THE SAMPLE. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE AND IT WAS NOTED THAT IT TOOK SEVERAL ATTEMPTS TO INSERT THE LEVER LOCK CANNULA INTO THE INJECTION SITE MEMBRANE IN BOTH Y SITES. FURTHER VISUAL INSPECTION OF THE Y SITES FOUND THAT THE CENTER SLIT IS OFF CENTER. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A MANUFACTURING DEFICIENCY. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT AN INTERLINK CONTINU-FLO SOLN SET 0.22 MICRON FILTER HAD AN INJECTION SITE MEMBRANE THAT WAS NOT ABLE TO BE PERFORATED. THIS WAS OBSERVED WHEN ADDING THE SECONDARY MEDICATION BAG USING THE CANNULA OF THE Y SITE LOCATED UPSTREAM OF THE IV SET. THE CONDITION OCCURRED BEFORE USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93353 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12H07079

    Patients

    Seq Age Sex Outcome Treatment
    1