MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. DIRECTCHECK QUALITY CONTROL ; PLASMA, COAGULATION CONTROL

Model Number DCJACT-N

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/16/2015

Event Type  malfunction  

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 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.

Manufacturer Narrative

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:.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: jon mcdermed ; 8 olsen avenue; edison, NJ 08820 ; 8582632490
• MDR Report Key: 4921129
• MDR Text Key: 6029185
• Report Number: 2250033-2015-00007
• 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
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: DCJACT-N
• Device Catalogue Number: DCJACT-N
• Device Lot Number: C5DNA007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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