BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IL BASIC VENTED SET

    MDR report key: 1903747 · Received November 20, 2010

    Report

    Report Number
    6000001-2010-05119
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: AFTER SEVERAL ATTEMPTS MADE BY BAXTER TO OBTAIN ADDITIONAL INFORMATION AND/OR THE SAMPLE, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE AND THE SAMPLE IS NOT AVAILABLE. ADDITIONAL INFORMATION: A LABEL REVIEW OF PRODUCT CODE JC6419 WAS CONDUCTED. ALTHOUGH THE LABEL WAS FOUND NOT TO HAVE A WARNING SPECIFIC TO THE REPORTED ISSUE, THE LABEL CONTAINS THE APPROPRIATE DIRECTIONS, CAUTIONS AND NOTES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT INVOLVED IS UNKNOWN. THE SAMPLE HAS BEEN INDICATED TO BE AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED AND/OR UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION CONFIRM METER WAS GIVING VARIABLE READINGS. TOOK BG LEVEL AND RESULTS WERE 465, HE TOOK OUT THE STRIP AND PUT IN A NEW STRIP, RESULT WAS 31, REMOVED STRIP, INSERTED NEW STRIP AND RESULTS WERE 173. HE USED A NEW DROP OF BLOOD EACH TIME. CUSTOMER DID NOT WAIT FOR ORDER TO BE SENT OUT, HE WENT TO (B)(6) AND PURCHASED NEW METER AND STRIPS. CONTROLS NOT USED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A CUSTOMER REPORTED A COMPLAINT REGARDING ONE UNIT OF PRODUCT CODE JC6419 TO BAXTER (B)(4). THE CUSTOMER REPORTED THAT DURING A PROCEDURAL SEDATION, ADDITIONAL PROPOFOL NEEDED TO BE GIVEN. WHEN THE SYRINGE WITH THE INTERLINK CANNULA WAS INSERTED IN THE TUBING PORT, THE RUBBER DISC DISLODGED. THE PROPOFOL BACKED UP AND THE SYSTEM WAS OPENED TO THE AIR. THE PATIENT WAS WAKING UP DURING THE PROCEDURE, AND THEY WERE UNABLE TO GIVE THE PATIENT MORE MEDICINE TO SEDATE HIM. THE PROBLEM WAS DURING USE AND THERE WAS A REPORT OF THE PATIENT WAKING UP DURING SEDATION. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IL BASIC VENTED SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention