BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3052555 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09028
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS NO TREND ALERT IDENTIFIED FOR THE PRODUCT CODE (B)(4) AND THE AS REPORTED PROBLEM CODE OF CONNECTION - DIFFICULT TO CONNECT. THE LOT NUMBER WAS NOT PROVIDED; AS SUCH A BATCH RECORD REVIEW COULD NOT BE PERFORMED. THIS COMPLAINT AND ANY ASSOCIATED TASKS WILL BE RE-OPENED ACCORDINGLY AND IF REQUIRED UPON RECEIPT OF ANY SAMPLES. THE REPORTED CONDITION COULD NOT BE CONFIRMED AND NO ASSIGNABLE CAUSE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE HAS BEEN RETURNED AND EVALUATED; THEREFORE, THE CODING HAS BEEN UPDATED. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, CLEAR PASSAGE TESTED AND PRESSURE TESTED. THE SET'S SLIDE CLAMP WAS FUNCTIONALLY TESTED AND THE SET WAS PRIMED. NO MALFUNCTIONS WERE IDENTIFIED DURING EVALUATION.

    Description of Event or Problem · 1

    ON (B)(4) 2013 BAXTER RECEIVED A REPORT REGARDING ONE (1) INTERLINK EXTENSION SET (PRODUCT CODE UNKNOWN, LOT UNKNOWN). THE CUSTOMER REPORTS THAT THEY HAVE ONGOING OCCURRENCES OF DIFFICULTY CONNECTING SMITHS MEDICAL WINGED PROTECT IV TO BAXTER EXTENSION SETS WITH LOSS OF IV ACCESS. THE CUSTOMER ADVISED THAT THERE HAVE BEEN TWENTY-TWO (22) SEPARATE OCCURRENCES WHILE USING BAXTER PRODUCT CODES (B)(4); THE CUSTOMER DID NOT SPECIFY THE DISTRIBUTION OF OCCURRENCES FOR EACH PRODUCT CODE. THE CUSTOMER HAS ADVISED THERE ARE SAMPLES FOR EVALUATION HOWEVER DID NOT SPECIFY THE QUANTITY NOR THE PRODUCTS CODES THAT THERE WERE SAMPLES OF. WHEN THE PROBLEM WAS NOTED IS UNKNOWN HOWEVER THERE IS NO PATIENT INJURY, INVOLVEMENT, OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENTS. THE CUSTOMER INDICATED THAT THEY ARE NOT GOING TO PROVIDE THE INDIVIDUAL FEEDBACK FORMS TO IDENTIFY THE DISTRIBUTION OF PRODUCT OCCURRENCES. THE CUSTOMER SPECIFIED THAT THE INCIDENTS OCCURRED BETWEEN (B)(6) 2012 AND (B)(6) 2013. SAMPLE AVAILABILITY IS CURRENTLY UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155194 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1