BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2798995 · Received October 22, 2012

    Report

    Report Number
    1416980-2012-02932
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE OF PRODUCT CODE (B)(4) WAS RETURNED ALONG WITH A (B)(4) 500ML EVACUATED CONTAINER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE (B)(4) EXTENSION SET HAS A BD LEVER LOCK ATTACHED TO THE IN-LET FEMALE LUER. VISUAL INSPECTION OF THE EXTENSION SET SHOWED THAT IT APPEARED NORMAL WITH NO COLLAPSED TUBING NOTED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    A SALES REP CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT AN UNKNOWN AMOUNT OF EXTENSION SETS IN WHICH THE TUBING COLLAPSED ON ITSELF AS BLOOD WAS BEING DRAWN. ACCORDING TO THE REPORT, THE FACILITY WAS USING THE 500ML EVACUATED CONTAINERS TO DRAW BLOOD THROUGH VENOUS ACCESS. THE FACILITY USES JELCO CATHETERS (18 X 1 3/4 GAUGE) AND CONNECT TO THE STANDARD INTERLINK CATHETER EXTENSION SET ((B)(4)). THEY THEN CONNECT THAT EXTENSION SET TO THE 1C8624 USING A LEVER-LOCK AND CLIP IT INTO THE INTERLINK INJECTION SITE. THEY USE A 16 - 18 GAUGE NEEDLE AT THE DISTAL END OF THE 1C8624 TO SPIKE INTO THE BOTTLE. THE FACILITY DOES NOT PRIME THESE SETS EVEN THOUGH IT SAYS TO ON THE LABEL COPY. THE BSR ADVISED THE FACILITY TO CONNECT THE SET LEVER LOCK INTO THE INJECTION SITE, OPEN THE ROLLER CLAMP SLOWLY, LET IT FILL WITH BLOOD, AND ONCE IT IS FILLED, OPEN THE ROLLER CLAMP ALL THE WAY AND ALLOW UNRESTRICTED FLOW. THE EVENTS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE - CLEVELAND GR303347

    Patients

    Seq Age Sex Outcome Treatment
    1