BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTCHECK QUALITY CONTROL

    MDR report key: 4921129 · Received July 15, 2015

    Report

    Report Number
    2250033-2015-00007
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GGN
    PMA / PMN Number
    K120977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON (B)(6) 2015 REFERENCES ITC COMPLAINT NUMBER # (B)(4). METHOD CODES: ACTUAL DEVICE NOT EVALUATED. DHR REVIEW WAS NOT PERFORMED AS THE COMPLAINT IS UNRELATED TO PRODUCT PERFORMANCE OR PACKAGING. NO TESTING METHODS PERFORMED. REVIEW OF THIS CASE DETERMINED THAT THE END USER HAD NOT BEEN FULLY TRAINED ON THE PROPER METHOD TO CRUSH THE DIRECTCHECK CONTROL VIAL. ITC CONTINUES TO REQUEST CLARIFICATION AS TO THE LOT NUMBER OF THE DIRECTCHECK CONTROL USED IN THIS COMPLAINT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLACK:

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AN INJURY OCCURRED TO AN END USER THAT WAS RECONSTITUTING A DIRECTCHECK QUALITY CONTROL FOR A HEMOCHRON SIGNATURE ELITE AND ACT MICROCOAGULATION SYSTEM. THIS CONTROL IS PACKAGED IN A GLASS AMPOULE ENCLOSED IN A CRUSHABLE VIAL. WHEN THE END USER CRUSHED THE VIAL TO ACTIVATE THE CONTROL, A SHARD OF GLASS PENETRATED HIS GLOVE AND PUNCTURED HIS LEFT THUMB. THE END-USER IMMEDIATE SOUGHT MEDICAL ATTENTION FOR HIS THUMB INJURY WITH EMPLOYEE HEALTH. THE GLASS WAS REMOVED FROM HIS THUMB AND A STERILE BANDAGE WAS APPLIED. THE END USER RETURNED TO WORK. IT IS NOT CLEAR WHETHER OR NOT THE END USER WAS WEARING THE PROTECTIVE SLEEVE PROVIDED BY ITC TO SAFEGUARD AGAINST POTENTIAL USER INJURY DURING RECONSTITUTION OF THE CONTROL. NO SIGNIFICANT BLOOD LOSS OCCURRED. THERE WERE NO COMPLICATIONS OR OTHER RELATED MEDICAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460457 DIRECTCHECK QUALITY CONTROL PLASMA, COAGULATION CONTROL GGN INTERNATIONAL TECHNIDYNE CORP. DCJACT-N C5DNA007

    Patients

    Seq Age Sex Outcome Treatment
    1