BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3892218 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20117
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OCCURRED WHEN THE INTERLINK CAME UNSCREWED FROM THE IV LINE. THE PATIENT BLED FROM THE IV LINE. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS UNDERWATER LEAK TESTED AND LIQUID LEAK TESTED WITH NO DEFECTS NOTED. THE REPORTED PROBLEM WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS ADDITIONALLY CLARIFIED THAT A NON-BAXTER T-CONNECTER BECAME DISCONNECTED FROM AN INTERLINK MALE LUER. EVALUATION SUMMARY: THE MALE LUER WAS ADDITIONALLY TESTED FOR ISO COMPLIANCY AND WAS FOUND TO MEET THE REQUIREMENTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HAVING CONNECTION ISSUES DURING THE USE OF AN INTERLINK INJECTION SITE. ACCORDING TO THE REPORT, THE CUSTOMER EXPERIENCED SEVERAL DISCONNECTIONS BETWEEN THE INTERLINK INJECTION SET AND A T-CONNECTOR SET WHICH RESULTED IN BLOOD LEAKS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 8 OF 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368420 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HOSPIRA T-CONNECTOR