BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3201785 · Received July 2, 2013

    Report

    Report Number
    1416980-2013-17021
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION BY BAXTER. FUNCTIONAL TESTING CONFIRMED THE REPORTED LEAK AT THE MALE-FEMALE LUER INTERFACE. THE CONDITION WAS DETERMINED TO BE CAUSE BY THE INNER DIAMETER OF THE FEMALE LUER, WHICH DID NOT MEET SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN OPENED IN ORDER TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED INTERLINK IV CATHETER EXTENSION SET A LEAK WAS FOUND. THE LEAK WAS FOUND AT THE CONNECTION OF THE FEMALE LUER AND A NON-BAXTER INJECTION SITE. PATIENT INVOLVEMENT IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301887 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12H31103

    Patients

    Seq Age Sex Outcome Treatment
    1