BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE

    MDR report key: 10520607 · Received September 10, 2020

    Report

    Report Number
    MW5096534
    Event Type
    Death
    Date Received
    September 10, 2020
    Date of Event
    May 22, 2020
    Report Date
    September 8, 2020
    Manufacturer
    ARROW INTERNATIONAL LLC / TELEFLEX, INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS TWO DAYS POST CABG WHEN HE SUFFERED A CARDIAC ARREST AFTER A BLOOD TRANSFUSION. DURING CPR, IT WAS NOTED THAT HIS TRIPLE LUMEN CATHETER HAD BECOME UN-ATTACHED AND ONE OF THE POTS WAS BROKEN AWAY FROM THE HUB - LEAVING THE PORT OPEN TO AIR. DURING INVESTIGATION, IT WAS NOTED THAT THE PLASTIC "TAIL" BROKE LOOSE FROM THE BLUE PLASTIC HUB (CONNECTION). THERE DID NOT APPEAR TO BE A CUT OR TEAR IN THE ACTUAL TUBING, IT APPEARED TO HAVE SEPARATED AT THE POINT OF ATTACHMENT WHERE IT IS GLUED INTO THE HUB. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983446 TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ARROW INTERNATIONAL LLC / TELEFLEX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death