BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2936258 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02366
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL AND FUNCTIONAL TESTING, THE DEVICE MET SPECIFICATION. PRESSURE TESTING AS WELL AS A LUER GAUGE TEST WAS ALSO PERFORMED AND THE DEVICE MET SPECIFICATION. THE DEVICE PASSED ALL TESTING AND MET SPECIFICATION; HOWEVER, THE DEVICE DID LEAK WHEN TESTED WITH THE NON-BAXTER DEVICE RETURNED BY THE CUSTOMER. THE CUSTOMER CLARIFIED THAT THE REPORTED EVENT DID NOT INVOLVE A "HUB-TO-HUB" METHOD.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW CANNOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A 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). AFTER FURTHER TESTING, THE FEMALE LUER WAS FOUND TO NOT MEET SPECIFICATION FOR THE INSIDE DIAMETER. THEREFORE, THE REPORT OF A LEAK WAS CONFIRMED. A CAPA HAS BEEN OPENED IN ORDER TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE ONE INTERLINK I.V. CATHETER EXTENSION SET IN WHICH LEAKING DURING HYDRATION INFUSION WAS DETECTED BETWEEN THE FEMALE CONNECTION OF THE INTERLINK SET AND A MICROCLAVE LUER INJECTION SITE. THE CUSTOMER REPLACED THE MICROCLAVE LUER ACTIVATED DEVICE THREE TIMES, BUT LEAKING RECURRED. THE CUSTOMER REMOVED THE MICROCLAVE AND EXTENSION SET AND USED A "HUB TO HUB" CONNECTION FOR THE REMAINDER OF INFUSIONS BY INSERTING THE END OF THE UNSPECIFIED PRIMARY IV TUBING DIRECTLY INTO THE PERIPHERALLY INSERTED IV CATHETER. THE EVENT OCCURRED IN THE ADULT ONCOLOGY DAY HOSPITAL. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40105 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12J21036

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCLAVE CONNECTOR (HOSPIRA CODE 12568-01)| 10ML NS POSIFLUSH SYRINGE| PRIMARY IV TUBING, CATHETER