MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. DIRECTCHECK QUALITY CONTROL

Catalog Number DCPRO-N

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

End user reports she was injured on her right hand, middle digit from a piece of material that pierced through the direct-check quality control during activation of the control vial.End user was not using the protective sleeve at the time of the incident.She performed standard first aid to the affected area.No report of serious injury or administration of medical treatment.Customer advised there were no signs of infection and the affected area is healing.

Manufacturer Narrative

References itc complaint number (b)(4).Method: actual device not evaluated.Process evaluation performed.Device history records reviewed and found to meet release specifications.No related ncrs or current complaint trends identified.Result: no results available since no evaluation performed.Conclusion: human factors issue.End user was not using protective sleeve at the time of the injury.The direct-check protective sleeve is provided as a means to reduce probability of cuts.The instructions for use indicates use of protective sleeve is required when control vials are activated.Each package includes an insert containing a picture demonstrating the preferred technique to use during activation of the assembly.In addition, the itc website includes a video which illustrates the preferred technique to use during activation of the assembly.End user was re-educated on the preferred technique to use during activation of directcheck.Itc has requested all data required for form 3500a.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 20 corporate place south; piscataway, NJ 08854 ; 7325485700
• MDR Report Key: 3633908
• MDR Text Key: 16799565
• Report Number: 2250033-2013-00009
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Catalogue Number: DCPRO-N
• Device Lot Number: E3DCP005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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