BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK Y-SITE, BULK, STERILE-THIS COMPONENT

    MDR report key: 1872668 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04133
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 24, 2010
    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

    THE SAMPLE IS AVAILABLE AND IS AWAITING RECEIPT BY THE SINGAPORE PLANT. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. IT WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. CRACKS WERE OBSERVED ON THE Y-SITE. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN AND AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON SEPTEMBER 24, 2010, AN INCIDENT WHERE CRACKS WERE FOUND AT THE HOUSING WITH THIS INTERLINK Y-SITE SET. THIS INCIDENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK Y-SITE, BULK, STERILE-THIS COMPONENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1