BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRELLIS-6 PERIPHERAL INFUSION SYSTEM

    MDR report key: 5470403 · Received March 1, 2016

    Report

    Report Number
    2183870-2016-00196
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    PMA / PMN Number
    K130904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH (B)(4), FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ODU WAS STOPPING PERIODICALLY DURING PROCEDURE, PHYSICIAN WAS DISCONNECTING ODU SO HE COULD ASPIRATE THROUGH WIRE LUMEN AND ODU WIRE BROKE OFF NEAR THE HUB. HE WAS ABLE TO PULL CATHETER OUT WITH BROKEN WIRE STILL INSIDE CATHETER. EVALUATION SUMMARY: UPON RECEIPT OF THE SAMPLE, THE DISPERSION WIRE WAS OBSERVED TO BE BROKEN 0.5CM FROM THE TIP OF THE HYPOTUBE. KINKED ALSO OBSERVED 0.2CM FROM THE TIP OF HYPOTUBE. THE OTHER BROKEN SEGMENTS OF DISPERSION WIRE REMAINS INSIDE THE CATHETER. KINKED ON CATHETER WAS OBSERVED AT THE TIP OF THE OUTER STRAIN RELIEF. NO OTHER ISSUES OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127255 TRELLIS-6 PERIPHERAL INFUSION SYSTEM CATHETER, CONTINUOUS FLUSH KRA COVIDIEN BVT612030 551476

    Patients

    Seq Age Sex Outcome Treatment
    1