BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERFOOT HEEL INCISION DEVICE

    MDR report key: 3570088 · Received November 12, 2013

    Report

    Report Number
    2250033-2013-00007
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    September 2, 2013
    Report Date
    October 15, 2013
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JCA
    PMA / PMN Number
    K883968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L EXPIRATION DATE: 04/2017. THIS MDR SUBMITTED 11/12/2013 (B)(4). THE USER FACILITY REPORTED TWO LOT NUMBERS. BE343M AND BD354. HOWEVER, THE SPECIFIC LOT NUMBER WHICH WAS USED DURING THE EVENT THAT CAUSED THE INJURY WAS UNABLE TO BE VERIFIED. METHOD CODES, ACTUAL DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED TO ITC. THE USER FACILITY RETURNED REOPENED PRODUCT OF LOT #BD354. THE CUSTOMER-RETURNED PRODUCT OF LOT# BD354 ABD ITC'S RESERVE SAMPLES FOR BOTH LOTS (BE343M AND BD354) WERE EVALUATED. DEVICE HISTORY RECORDS FOR BOTH LOT NUMBERS (BE343M AND BD354) WERE REVIEWED AND FOUND PRODUCT TO MEET RELEASE SPECS. NO NON-CONFORMANCES OR OTHER ANOMALIES IDENTIFIED. NO CURRENT COMPLAINT TRENDS WAS FOUND FOR THIS PRODUCT/ISSUE. RESULT CODE: THE COMPLAINT AGAINST LOTS (BE343 AND BD354) WAS NOT CONFIRMED THROUGH THE EVAL TESTING. CUSTOMER-RETURNED SAMPLES FOR LOT# BD354 AND RESERVE SAMPLES OF BOTH LOTS (BE343M AND BD354) MET SPECS. ITC HAS REQUESTED ALL DATA REQUIRED FOR 3500A.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTS END USER WAS INJURED DURING USE OF THE TENDERFOOT NEWBORN HEEL INCISION DEVICE. WHILE THE END USER WAS PERFORMING THE HEEL STICK PROCEDURE ON AN INFANT, THE PLASTIC CASING HALVES OF THE DEVICE DISASSEMBLED AND END USER RECEIVED A CUT FROM THE EXPOSED BLADE TO HER LEFT RING 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 PTC. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584965 TENDERFOOT HEEL INCISION DEVICE JCA INTERNATIONAL TECHNIDYNE CORP. BE343M, BD354

    Patients

    Seq Age Sex Outcome Treatment
    1