BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 3873382 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19027
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE CLABSI OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR MAY HAVE CONTRIBUTED TO A CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION (CLABSI). TREATMENT AND PATIENT OUTCOME WERE NOT REPORTED. THE CUSTOMER REPORTED THAT ¿THE NURSES WERE NOT TIGHTENING THE CAPS¿ AND STATED THAT THIS MAY HAVE LED TO THE CLABSI, HOWEVER, THIS WAS NOT CONFIRMED. THERE WAS NO REPORT OF DAMAGE, LEAK OR OF A CONNECTION ISSUE REGARDING THE SET. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350129 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other