BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTIV PLUS-W SAFETY I.V CATHETER RADIOPAQUE 20X11/4

    MDR report key: 1192435 · Received October 7, 2008

    Report

    Report Number
    1219611-2008-00006
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MFG FOR SMITHS MEDICAL BY: MEDEX
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVAL: OUR INVESTIGATION INTO THIS EVENT IS LIMITED AS NO SAMPLE WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE MFG RECORDS REVEALS NO INFO THAT WOULD INDICATE A DEVICE FAILURE. A REVIEW OF OUR COMPLAINTS DATABASE REVEALS NO OTHER REPORTS ON THIS DEVICE LOT NUMBER. WITHOUT THE ACTUAL EVENT SAMPLE WE ARE UNABLE TO DETERMINE IF A QUAL ISSUE RESULTS WITH THE EVENT SAMPLE. IT IS OUR MFG EXPERIENCE, THAT INCORRECT INSERTION/THREADING TECHNIQUES CAN CAUSE CATHETER TIP DAMAGE DURING THE INSERTION PROCESS. PREMATURE ADVANCEMENT OF THE CATHETER OVER THE TOP OF THE NEEDLE MAY CAUSE THE CATHETER TIP TO FOLD INWARD AND SPLIT/SHEAR DUE TO THE LACK OF SUPPORT FROM THE NEEDLE. SMITHS INSTRUCTIONS FOR USE (IFU) STATES THAT THE DEVICE SHOULD BE HELD AT AN APPROPRIATE ANGLE DURING INSERTION. THE IFU ALSO STATES THAT THE USER ADVANCE THE CATHETER AND NEEDLE TOGETHER TO ASSURE FULL CATHETER ENTRY INTO THE VEIN LUMEN. IF THE VENIPUNCTURE IS NOT SUCCESSFUL, THE USER SHOULD DISCARD BOTH NEEDLE AND THE CATHETER. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    USER ALLEGES THAT DURING THE RETRIEVAL OF THE CATHETER, IT BROKE AND PART OF IT REMAINED IN THE VEIN. THE PT HAD A VASCULAR PROCEDURE TO EXTRACT THIS PART WITH NO SUCCESS. EVENT OCCURRED IN OTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTIV PLUS-W SAFETY I.V CATHETER RADIOPAQUE 20X11/4 80-FOZ I.V. CATHETER FOZ MFG FOR SMITHS MEDICAL BY: MEDEX 37E29SE04

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention