BEUDAMED
    FDA Adverse Event Summary report: N

    INTERLINK I.V. CATHETER EXT SET/MALE LL ADAPTER

    MDR report key: 1810466 · Received August 20, 2010

    Report

    Report Number
    6000001-2010-02682
    Date Received
    August 20, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL INTERLINK SUBASSEMBLY, AN ACTUAL INTERLINK SET, AND A COMPANION SAMPLE WERE SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE ACTUAL SAMPLE CONFIRMED THE REPORTED CONDITION OF THE SEPTUM BEING PARTIALLY INVERTED . THE SEPTUM WAS REMOVED AND CHECKED FOR A CENTER SLIT. THE CENTER SLIT WAS FOUND TO BE PRESENT. THE SECOND USED SAMPLE ARRIVED WITH A BD BLUNT CANNULA INSERTED INTO THE SEPTUM. VISUAL INSPECTION SHOWED THAT, THE SEPTUM WAS INTACT. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFECT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR DISTRIBUTOR THAT A BLOOD BACKFLOW OCCURRED DUE TO AN INVERTED SEPTUM WHEN USING THE INTERLINK CATHETER EXTENSION SET. THE CATHETER IS INSERTED INTO THE PATIENT'S ARM AND AFTER AN UNKNOWN AMOUNT OF TIME, BLOOD BACKS UP INTO THE EXTENSION TUBING. THIS CONDITION STARTED OCCURRING 2 OR 3 MONTHS AGO. THE CUSTOMER HAS NOT CHANGED PRODUCTS OR PROCEDURES. THE INJECTION SITE IS ACCESSED WITH A BD BLUNT CANNULA, PRODUCT CODE 303345. THE INTERLINK IS ACCESSED STRAIGHT IN AND THE RUBBER PORTION WILL "FLIP" OUT. THE CUSTOMER REPORTED THAT THE SLIT ON THE INTERLINK IS NOT ALWAYS IN THE MIDDLE, SOMETIMES IT IS ON THE SIDE OF THE INJECTION SITE. REGARDLESS OF THE POSITION OF THE SLIT, WHEN ACCESSED THE SEPTUM WILL INVERT CREATING AN OPEN SYSTEM AND BLOOD WILL BACK UP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK I.V. CATHETER EXT SET/MALE LL ADAPTER SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1