BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK INJECTION SITE

    MDR report key: 1943073 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06480
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED CORPORATE PRODUCT SURVEILLANCE REGARDING THE INTERLINK INJECTION SET THAT IS LEAKING. THEIR CUSTOMER REPORTED TO THEM THAT EVERY TIME THEY USED THE INTERLINK, FLUID SPAYED EVERYWHERE. THERE WAS NO REPORT OF EXPOSURE AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE CONDITION OCCURRED DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK INJECTION SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE NIA

    Patients

    Seq Age Sex Outcome Treatment
    1