BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2120937 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07556
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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). ONE ACTUAL SAMPLE WAS RETURNED TO THE PLANT FOR EVALUATION. THE REPORTED CONDITION OF "LEAKS" WAS NOT CONFIRMED. A BATCH REVIEW WAS PERFORMED AND NO ABNORMALITIES WERE FOUND. THEREFORE, AN ASSIGNABLE ROOT CAUSE COULD NOT BE IDENTIFIED. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET WITH 2-PORT MANIFOLD IN WHICH THE GLAND INSIDE OF THE PORT EITHER SEPARATED FROM THE PORT OR WAS MISSING INITIALLY. ACCORDING TO THE REPORT, AFTER FINISHING A PIGGYBACK INFUSION OF AN UNKNOWN ANTIBIOTIC, THE NURSE DISCONNECTED A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET USED AS A SECONDARY INTERMITTENT LINE FROM A PORT ON THE PRIMARY TUBING AND THE NURSE DID NOT CHECK THAT PORT AFTER REMOVING THE TUBE. SOON AFTER, THE NURSE OBSERVED FLUID AND BLOOD COMING OUT OF THE PORT AND NOTICED THE SELF SEALING PROTECTOR (GLAND) WAS MISSING. THE REPORTER STATED "YOU CAN SEE THE HARD PLASTIC THAT I ASSUME IS INSIDE THE PORT, WHICH IS WHERE THE SELF SEALING CAP OF THE PORT IS SUPPOSED TO BE." THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR11C22054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANTIBIOTIC