BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT HEEL INCISION DEVICE

    MDR report key: 3966516 · Received June 26, 2014

    Report

    Report Number
    2250033-2014-00004
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED (B)(4) 2014, REFERENCES ITC COMPLAINT CASE (B)(4). PATIENT CODE: THE END USER REPORTED EXPERIENCED A NEEDLE STICK/PUNCTURE. DEVICE CODE: NO INFORMATION DEVICE HAS BEEN RETURNED TO MANUFACTURER AN IS CURRENTLY UNDERGOING EVALUATION. METHOD CODE: NO TESTING METHODS PERFORMED. DEVICE HAS BEEN RETURNED TO MANUFACTURER AND IS CURRENTLY UNDERGOING EVALUATION. RESULT CODE: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION CODE: CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS END USER WAS INJURED DURING USE OF THE TENDERFOOT. THE TENDERFOOT DEVICE FELL APART IN THE USERS HAND AFTER THE DEVICE WAS USED ON THE PATIENT. THE NURSE SUSTAINED A PUNCTURE TO THE LEFT POINTER FINGER. THE HOSPITAL'S NEEDLE STICK INJURY PROCEDURE WAS FOLLOWED, INCLUDING REPORTING AND BLOOD SPECIMEN TESTING. AT THIS TIME, NO SUBSEQUENT ADVERSE EVENTS ASSOCIATED WITH THIS EVENT HAVE BEEN REPORTED TO ITC. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373820 TENDERFOOT HEEL INCISION DEVICE DEVICE, BLEEDING TIME JCA INTERNATIONAL TECHNIDYNE CORP. TF50I BC309M

    Patients

    Seq Age Sex Outcome Treatment
    1