BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INJECTABLE MULTI-LUMEN CVC KIT

    MDR report key: 2173085 · Received July 14, 2011

    Report

    Report Number
    2173085
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ARROW
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH 35% TOTAL BODY SURFACE BURNS ON CHEST WAS UNDERGOING LINE CHANGES EVERY THREE DAYS. AS THE RESIDENT STARTED TO PLACE THE WIRE, IT FRACTURED AND STARTED TO UNRAVEL UNDERNEATH THE PATIENT'S CLAVICLE. THE INCISION HAD TO BE EXTENDED IN ORDER TO REMOVE THE WIRE. OTHER THAN THE CUT DOWN, THE PATIENT HAD NO OTHER SEQUELA FROM THIS INCIDENT.======================MANUFACTURER RESPONSE FOR CVC KIT, PRESSURE INJECTABLE MULTI-LUMEN CVC KIT (PER SITE REPORTER)======================LOT PULLED FROM CENTRAL DISTRIBUTION AND UNITS. ACCORDING TO AN EMAIL RECEIVED FROM THE FIRM: "WE WENT TO THE SICU AND BURN UNIT TO LOOK FOR THE LOT NUMBER IN QUESTION. NO KITS ON EITHER UNIT WERE FOUND. WE WERE ABLE TO FIND ONE CASE IN CD. ARROW HAS ISSUED A CREDIT FOR RETURN. WE WILL SEND THE UF ANOTHER CASE TO REPLACE THE LOT NUMBER IN QUESTION. UF USES (B)(4) TRIPLE LUMEN KITS. UF HAS REPORTED HAVING 4 SPRING WIRE-GUIDES (SWG) UNRAVEL WITHIN THE LAST MONTH. THIS IS A LESS THEN 1% OCCURRENCE THROUGHOUT THE YEAR. BASED ON THAT INFORMATION, IT WAS MOST LIKELY A BAD LOT OF KITS. THE NUMBERS ALSO SHOW THAT IT IS NOT A TECHNIQUE ISSUE.IF THERE ARE ANY OTHER SWG ISSUES, PLEASE HAVE THE UNITS KEEP THE PRODUCT AS WELL AS LID-STOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE INJECTABLE MULTI-LUMEN CVC KIT CATHETER, PERCUTANEOUS DQY ARROW CDC-45703-XP1A RF1046257

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR