BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOLINK MICROBORE CATH EXT SETW/POSITIVE FLUID DISPLACEMENT

    MDR report key: 1973409 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00503
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K042936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED 3 UNUSED SAMPLES AND ONE UNKNOWN SYRINGE. THE SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE SAMPLES WERE CONNECTED TO THE RETURNED SYRINGE AND THERE WAS NO SEPARATION OBSERVED. NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE THAT AN PREFILLED 10CC NORMAL SALINE SYRINGE FROM CARDINAL HEALTH, CATALOGUE NUMBER SA1010A, IS SEPARATING FROM THE FLOLINK MICROBORE CATHETER EXTENSION SET. THE SEPARATION IS OCCURRING WITHIN SECONDS OF CONNECTING THE TWO. THE FLOLINK LUER IS NOT SECURELY CONNECTING TO THE SYRINGE, AND WILL DISCONNECT FROM THE LUER. THIS CAUSES THE SOLUTION TO LEAK OUT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOLINK MICROBORE CATH EXT SETW/POSITIVE FLUID DISPLACEMENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 PREFILLED 10CC NORMAL SALINE SYRINGE