BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 2024377 · Received March 18, 2011

    Report

    Report Number
    6000001-2011-01983
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 04/04/2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED A CUT ON THE TUBING. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN INTERLINK SYSTEM CONTINU-FLO SOLUTION SET IN WHICH THE TUBING WAS FOUND TO BE COMPLETELY SEVERED DIAGONALLY. THE CONDITION WAS IDENTIFIED BEFORE USE WHEN THE PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT OR INJURY IS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR11A11044

    Patients

    Seq Age Sex Outcome Treatment
    1