BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIPLE LUMEN KIT

    MDR report key: 17877426 · Received October 4, 2023

    Report

    Report Number
    MW5146609
    Event Type
    Other
    Date Received
    October 4, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 2, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP-NORTHFIELD
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 49-YEAR-OLD MALE PATIENT PRESENTED TO ED(EMERGENCY DEPT) DUE TO PERIUMBILICAL ABDOMINAL PAIN. CT SCAN SHOWED AN INCARCERATED ABDOMINAL HERNIA. THE PATIENT WAS BROUGHT TO THE OR(OPERATING ROOM) FOR AN EMERGENT REPAIR OF INCARCERATED UMBILICAL HERNIA. A RIGHT FEMORAL CENTRAL LINE WAS INSERTED OVER A GUIDE WIRE. CENTRAL LINE WAS ADVANCED WITHOUT DIFFICULTY, AND THE GUIDE WIRE WAS REMOVED. ALL PORTS WERE ASPIRATED FOR BLOOD AND FLUSHED WITH SALINE. THERE WAS NO RESISTANCE NOTED ON ALL PORTS. THE CATHETER WAS SECURED TO THE SKIN AND CENTRAL LINE DRESSING WAS APPLIED. THE CATHETER WAS IMMEDIATELY READY FOR USE. THERE WERE NO OBVIOUS SIGNS OF RETAINED CATHETER AND UNCLEAR IF THERE WAS A DEFECT IN THE WIRE. ON (B)(6) 2023 CT OF THE ABDOMEN SHOWED A RADIODENSE FOREIGN BODY OBJECT LIKELY WIRE OVERLYING THE DISTRIBUTION OF THE INFERIOR VENA CAVA. THE PATIENT UNDERWENT A TRANS CATHETER RETRIEVAL OF WIRE. IT IS UNCLEAR IF THERE WAS A DEFECT IN THE WIRE. RADIODENSE FOREIGN BODY AND LIKELY WIRE OVERLYING THE DISTRIBUTION OF THE INFERIOR VENA CAVA SPANNING FROM THE VISUALIZED MID ABDOMEN TO THE PELVIC INLET MEASURING 31 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225954 TRIPLE LUMEN KIT GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, LP-NORTHFIELD ECVC5400

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention