BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR

    MDR report key: 7004119 · Received November 6, 2017

    Report

    Report Number
    1416980-2017-08820
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    September 20, 2017
    Report Date
    November 6, 2017
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDWATCH# 5072283. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BACKFLOW OF BLOOD THROUGH AN EXTENSION SET WITH ONE-LINK NEEDLE-FREE IV CONNECTOR. THE REPORTER STATED THAT AFTER THE PATIENT WAS CONNECTED, THE LINE WAS FLUSHED WITH SALINE SOLUTION AND CLAMPED. AN UNSPECIFIED AMOUNT OF THE PATIENT¿S BLOOD THEN BACKFLOWED INTO THE SET AND LEAKED OUT OF THE SET AT THE ¿HUB DISTAL TO LUER LOCK CONNECTOR BUT BEFORE CLAMP.¿ THE SET WAS REPLACED TO RESOLVE THE ISSUE. 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
    783197 EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO NA UR17F07094

    Patients

    Seq Age Sex Outcome Treatment
    1