BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYSTEM

    MDR report key: 7894742 · Received September 20, 2018

    Report

    Report Number
    1416980-2018-06049
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 20, 2018
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    UDI-DI
    05413760241050
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THREE SAMPLES WERE RECEIVED FOR EVALUATION. THE SAMPLES UNDERWENT VISUAL INSPECTION BY THE NAKED EYE, "AT" IS WAS CONFIRMED THAT THE POUCH WAS OPEN. FURTHER VISUAL INSPECTION WITH THE NAKED EYE REVEALED THAT THE SEAL CREATED ON THE POUCH WAS WEAK. THE REPORTED ISSUE WAS VERIFIED, THE CAUSE WAS DETERMINED TO BE DUE TO HUMAN ERROR DURING MANUFACTURING, THE PACKING FILM IS RECEIVED AS A REEL AND LOADED ON THE PACKAGING MACHINE. HOWEVER IN THIS CASE, THE REEL WAS MISTAKENLY LOADED IN REVERSE, (LEFT EDGE ON THE RIGHT) RESULTING IN THE ADHESIVE SIDE ON THE OUTSIDE OF THE POUCH. IT WAS DETERMINED THAT BY REPLACING THE 2-WAY BEARING WITH AN IDENTICAL 1-WAY BEARING, THIS WOULD INHIBIT THE USER LOADING THE REEL IN REVERSE. THE INSTALLATION OF THE ONE WAY BEARING WAS COMPLETED ON THE 17TH JUNE 2017. AT THE TIME OF PRODUCTION AND DURING IN PROCESS TESTING, THE SEAL CONFORMED TO STANDARD AND ANY NON-CONFORMITIES WOULD HAVE BEEN NOTICED. FURTHERMORE, AS A PRECAUTION IT IS NOTED THAT THE POUCH INSTRUCTIONS STATE ¿DO NOT USE IF PACKAGE HAS BEEN PREVIOUSLY OPENED OR DAMAGED OR IF STERILITY PROTECTORS ARE LOOSE OR MISSING¿. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING SEAL OF A INTERLINK SOLUTION SET WAS FAULTY, FURTHER DESCRIBED AS "AN OPENING WAS PRESENT". THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734995 INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA NA 15J31V297 05413760241050

    Patients

    Seq Age Sex Outcome Treatment
    1