BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYSTEM T-CONNECTOR EXTENSION SET

    MDR report key: 6139700 · Received December 1, 2016

    Report

    Report Number
    1416980-2016-17902
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    July 26, 2016
    Report Date
    January 9, 2017
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REGISTERED NURSE CLARIFIED THE EVENT. THE EVENT OCCURRED AT THE TIME OF THE HOSPITAL¿S 96 HOUR PROTOCOL ROUTINE TUBING CHANGE ON A PATIENT RECEIVING A CONTINUOUS INFUSION (INFUSION SOLUTION NOT REPORTED). ADDITIONALLY, THE PATIENT HAD NO LINE ACCESS AFTER REMOVAL OF THE PICC LINE. THE EVENT WAS FURTHER CLARIFIED AS THE BROKEN MALE LUER OF THE T-CONNECTOR IN THE LINE MADE CVL (CENTRAL VENOUS LINE) LUMEN NON-FUNCTIONAL AND THE ENTIRE LINE WAS REMOVED. IT WAS NOT POSSIBLE TO APPLY A DEADEND CAP (NOT FURTHER CLARIFIED). THIS EVENT CAUSED A DELAY IN THERAPY WHICH WAS REPORTED TO BE GREATER THAN 5 MINUTES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY LONG TERM COMPLICATIONS. STAFF WAS RETRAINED IN THE PROPER USE OF THIS DEVICE (NOT FURTHER SPECIFIED). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET HAD DAMAGED. THIS OCCURRED DURING PATIENT INFUSION. IT WAS STATED THAT THE MALE EXTENSION FROM THE SET HAD BROKEN OFF INSIDE THE PICC LINE. THE PICC LINE WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788850 INTERLINK SYSTEM T-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR