BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4110002 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32792
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION WITHOUT THE POUCH. A VISUAL INSPECTION WAS PERFORMED AND A TEAR ON TUBING AT THE CONNECTION BETWEEN TUBING AND FEMALE LUER LOCK ADAPTER WAS OBSERVED. AN UNDERWATER PRESSURE TEST WAS PERFORMED; A LEAK WAS OBSERVED AT THE LOCATION OF THE TORN TUBING. THE CAUSE COULD NOT BE DETERMINED. A CAPA WAS INITIATED TO INVESTIGATE THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK T-CONNECTOR SET LEAKED DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589632 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1