BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2210645 · Received August 12, 2011

    Report

    Report Number
    6000001-2011-18705
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF THE CUSTOMER DECIDES TO SEND IN THE SAMPLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION WITH THE CUSTOMER, IT HAS BEEN CONCLUDED THAT THIS REPORT WAS ERRONEOUS AND THERE IS NO ALLEGED DEFICIENCY AGAINST THIS PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN INTERLINK SET IN WHICH THERE WAS A LEAKAGE OF BLOOD FROM THE CAP END OF THE LINE. THE PROCESS STEP WAS DURING PATIENT USE AND NO PATIENT INJURY OR MEDICAL INTERVENTION IS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO 17012

    Patients

    Seq Age Sex Outcome Treatment
    1