BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR

    MDR report key: 11729177 · Received April 26, 2021

    Report

    Report Number
    1416980-2021-02436
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412475400
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION USING THE NAKED EYE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ALL COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS CONNECTED AT THE FEMALE AND MALE LUER CONNECTOR AND FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING; AND THE DEVICE PERFORMED ACCORDING TO PRODUCT SPECIFICATIONS. THE REPORTED CONDITION WAS NOT VERIFIED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURER ADDRESS: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE-LINK CATHETER EXTENSION SET WAS LEAKING FROM THE JUNCTION BETWEEN THE HUB AND THE LINE EXTENSION. THE LEAK WAS DISCOVERED WHILE THE PATIENT WAS CONNECTED FOR CONTRAST INJECTION. THERE WAS NO 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
    621374 EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R20L08088 00085412475400

    Patients

    Seq Age Sex Outcome Treatment
    1