MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. DRECTCHECK QUALITY CONTROL, NORMAL ACT+

Model Number DCJACT-N

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on 09/15/2015 references itc complaint number (b)(4).Method: actual device was not evaluated.Dhr review was not performed as the complaint is unrelated to product performance or packaging.No testing methods performed.Results: no results available since no evaluation performed.Conclusion: human factors issue.Training deficiency.Device not returned.Review of this case determined that the end user not been fully trained on the proper method to crush the directcheck control vial and administer the control.Itc has requested all data required for form 3500a.

Event Description

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 quality control is packaged in a glass ampule enclosed in a crushable vial.A protective sleeve is provided to protect the end user from injury.The end user crushed the vial to activate the control.She removed the sleeve to apply the control to the device's sample well and sustained a small cut to the second digit of her left hand by a shard of glass that penetrated the protective sleeve.The open wound drew some blood, so the end user squeezed her finger under running water and applied a sterile bandage.No significant blood loss occurred.The end user did not report any complications, wound infection or other medical issue related to the complaint.

• Brand Name: DRECTCHECK QUALITY CONTROL, NORMAL ACT+
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer (Section G): INTERNATIONAL TECHNIDYNE CORP.; 23 nevsky st.; edison NJ 08820
• Manufacturer Contact: jon mcdermed ; 8 olsen ave.; edison, NJ 08820 ; 8582632490
• MDR Report Key: 5084097
• MDR Text Key: 26192620
• Report Number: 2250033-2015-00008
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: DCJACT-N
• Device Catalogue Number: DCHACT-N
• Device Lot Number: D5DNA009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1