BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-LINK NEUTRAL LUER ACTIVATED DEVICE

    MDR report key: 9960079 · Received April 14, 2020

    Report

    Report Number
    1416980-2020-02179
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H9 CORRECTION/REMOVAL REPORT NUMBER: 8040700¿12/04/19¿001-C. H10: THE ACTUAL ONE LINK DEVICE WAS NOT RETURNED; HOWEVER, A CASE OF UNUSED NON-BAXTER SYRINGES WAS RECEIVED FOR EVALUATION. FIVE (5) NON-BAXTER SYRINGES WERE GAGE TESTED AND PASSED, HOWEVER, THEY WERE FOUND TO BE NARROW WHICH COULD CONTRIBUTE TO CONNECTION ISSUES. FOUR (4) IN-HOUSE ONE-LINK SAMPLES WERE USED TO SIMULATE USAGE WITH THE ONE-LINK COMPONENT. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO CONNECT THE NON-BAXTER SYRINGES TO THE ONE-LINK WITHOUT SWABBING THE ONE-LINK AND THEN RE-ATTEMPTED AFTER SWABBING THE ONE-LINK INLET SURFACE WITH A DISINFECTANT PAD. NONE OF THE FIVE (5) SYRINGES CONNECTED TO THE ONE-LINK PRIOR TO SWABBING, HOWEVER ALL FIVE (5) SYRINGES CONNECTED TO THE ONE-LINK ON THE FIRST TRY AFTER THE ONE-LINK WAS SWABBED WITH AN ALCOHOL PAD. IT WAS NOTED HOWEVER THAT THE INDIVIDUAL ALCOHOL PADS LOSE THEIR ABILITY TO HELP SECURE THE CONNECTION THE MORE THEY ARE EACH USED. LEAK TESTING WAS PERFORMED BY CONNECTING A 21-GAGE NEEDLE TO THE MALE LUER OF THE ONE-LINK THAT REMAINED CONNECTED TO THE NON-BAXTER SYRINGE. A BOLUS WAS PUSHED THROUGH THE SYSTEM, AND NO LEAKS OR DISCONNECTIONS WERE OBSERVED. THE CONNECTION BETWEEN THE ONE-LINK AND THE SYRINGE REMAINED SECURE AFTER APPLYING THE BOLUS. DOCKING STABILITY FUNCTIONAL TESTING WAS PERFORMED AND FOUND THAT THE NON-BAXTER SYRINGE CAN DOCK TO THE ONE-LINK WHEN USING PROPER CONNECTION TECHNIQUE (SWAB THE ONE-LINK, PUSH AND TWIST). IN-HOUSE DISINFECTANT CAPS WERE APPLIED TO THE FOUR (4) ONE-LINKS AND LEFT ON FOR TWENTY SECONDS. AFTER THE TWENTY SECONDS, THE CAPS WERE REMOVED FROM THE ONE-LINKS AND THE SYRINGES WERE SUCCESSFULLY CONNECTED TO THE ONE-LINKS WITH NO ISSUES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ONE-LINK NEEDLE-FREE IV (INTRAVENOUS) CONNECTORS HAD CONNECTION/DISCONNECTION ISSUES WITH NON-BAXTER SYRINGES; THIS WAS FURTHER DESCRIBED AS THE USER ¿COULD NOT MANAGE TO GET THE SYRINGE TO STAY INSIDE THE ONE-LINK CONNECTOR WITHOUT POPPING OFF, REGARDLESS OF THE SWABBING AND THE STRENGTH USED TO PUSH THE SYRINGE IN THE CONNECTOR¿. THIS ISSUE WAS IDENTIFIED DURING SETUP AND TESTING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422291 ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1