BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    MDR report key: 3812549 · Received April 17, 2014

    Report

    Report Number
    1820334-2014-00174
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    December 29, 2013
    Report Date
    March 21, 2014
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT AWAITING HEART AND LUNG TRANSPLANT UNDERWENT DRIP VIA PIC LINE. THERE BECAME A COMPLETE OCCLUSION OF THE LINE. THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS DISCARDED. PERFANE ON DRIP ALONE (HIGHLY IRRITATING MEDICATION NOT COMPATIBLE WITH PERFUSION TAP). DAY 5: ABNORMAL INCREASE OF PRESSURE WITH DRIP. DAY 12: COMPLETE OCCLUSION OF THE LINE. COMPATIBILITY OF MEDICATION AND DEVICE IS DODGY. PICLINE STILL ON PATIENT. CONSEQUENCES: TREATMENT WAS PARTIALLY STOPPED. RISKS OF INFECTION LINKED TO THE ATTEMPTS TO CLEAR FOR THE LINE FOR A WEEK. NEW LINE FITTED. PER COMPLAINT FORM: "THE CATHETER WAS CLOGGED AFTER 5 DAYS OF TREATMENT, THE NURSE HAD CHANGED THE VALVE BUT IT DOESN'T SOLVE THE OCCLUSION." "THE DOCTOR HAD TO PLACE ANOTHER CATHETER, BUT NOT A PICC LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236092 SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET FOZ COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN