BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950682 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03329
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 16, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ADDITIONAL DEVICE ANALYSIS WAS COMPLETED. DURING VISUAL AND FUNCTIONAL TESTING, THE DEVICE MET SPECIFICATION. PRESSURE TESTING, AS WELL AS A LUER GAUGE TEST WERE PERFORMED AND THE DEVICE MET SPECIFICATION. THE DEVICE PASSED ALL TESTING AND MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED UNIT WAS RECEIVED FOR EVALUATION RELATED TO A LEAKS-DISCONNECTION CONDITION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED PROBLEM WAS NOT CONFIRMED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. NO CONCLUSION COULD BE DRAWN FROM THE INVESTIGATION. IF RELEVANT ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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. 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 WITH WHICH LEAKING WAS DETECTED BETWEEN THE FEMALE HUB OF THE EXTENSION SET AND A NON-BAXTER LUER ACTIVATED DEVICE (LAD) INJECTION SITE, WHICH HAD BEEN SWAPPED IN PLACE OF THE INTERLINK INJECTION SITE. THE PATIENT RECEIVED THEIR PRE-MEDICATION VIA PERIPHERAL IV AT 11:30 AM. AT APPROXIMATELY 12:00 PM, THE PATIENT COMPLAINED OF FEELING "A BIT OF WETNESS" AT THE IV SITE. THE NURSE NOTED A MILD LEAK AT THE CONNECTION OF THE INTERLINK EXTENSION SET HUB AND THE NON-BAXTER LAD. THE NON-BAXTER LAD WAS REPLACED AND NO LEAKING WAS DETECTED UPON FLUSHING. THE PATIENT THEN RECEIVED UNSPECIFIED MEDICATION WITHOUT ANY LEAKING, INITIALLY, BUT LATER LEAKING AGAIN DEVELOPED DURING POST HYDRATION. THE NURSE REPLACED BOTH THE INTERLINK EXTENSION SET AND NON-BAXTER LAD, WITH NO FURTHER LEAKING DETECTED UPON FLUSHING. THE EVENT OCCURRED IN THE (B)(6) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54687 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCLAVE LAD CONNECTOR (12568-01, 03186)| UNKNOWN MEDICATION