BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT

    MDR report key: 1733909 · Received June 22, 2010

    Report

    Report Number
    1733909
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 22, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS PERFORMING A HEEL STICK ON AN INFANT. SHE OPENED THE TENDERFOOT DEVICE AND REMOVED THE SAFETY LOCK. THE INFANT'S HEEL HAD BEEN PREPPED. THE RN PLACED THE DEVICE ON THE HEEL AND ACTIVATED IT BY PUSHING THE SLIDE BAR. NORMALLY, THE DEVICE WOULD AUTO-LANCE THE INFANT'S HEEL. HOWEVER, IN THIS INSTANCE, THE DEVICE SPLIT OPEN AND THE LANCING DEVICE CAME OUT OF THE SIDE INSTEAD OF AT THE OPENING IN THE BOTTOM OF THE DEVICE. THE INFANT AND RN WERE NOT HURT. HOWEVER, HAD THE RN BEEN HOLDING THE DEVICE IN A DIFFERENT WAY, THE RN COULD HAVE BEEN CUT BY THE LANCET. THE RN OBTAINED ANOTHER DEVICE AND DREW THE INFANT'S BLOOD. THE RN'S ON THE UNIT HAVE NOT HAD THIS EXPERIENCE WITH THIS TYPE OF DEVICE BEFORE. ALL ARE EXPERIENCED USERS. PRIOR TO USING THE DEVICE, THERE WAS NO INDICATION THAT THE DEVICE WOULD FAIL OR WAS FAULTY IN ANY WAY. NO UNUSUAL OR EXCESSIVE FORCE/PRESSURE WAS APPLIED TO THE DEVICE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================STAFF DOES NOT KNOW WHY THE DEVICE FAILED OR WHAT COULD HAVE CAUSED IT TO DO SO.====================== MANUFACTURER RESPONSE FOR TENDERFOOT HEEL INCISION DEVICE======================WE ARE AWAITING INSTRUCTIONS TO RETURN THE DEVICE TO THE MANUFACTURER FOR THEIR INVESTIGATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDERFOOT NEWBORN HEEL INCISION DEVICE FMK INTERNATIONAL TECHNIDYNE CORP. * BB062

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA NO OTHER THERAPIES