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

Catalog Number DCJACT-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Healthcare professional reports a end user was injured on her right thumb when using the direct check quality control.The end user was not using the protective sleeve at the time of incident.She performed standard first aid to the affected area.No report of serious injury or administration of medical treatment.Per follow-up communication, the end user advised the affected areas has healed.

Manufacturer Narrative

(b)(4).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.Conclusion - end user was not using the protective sleeve at the time of injury.The direct check protective sleeve is provided as a means to reduce probability of cuts.Itc has requested all data required for form 3500a.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; 23 nevsky st.; edison NJ 08820
• Manufacturer (Section G): INTERNATIONAL TECHNIDYNE CORP.; 23 nevsky st.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 20 corp place s; piscataway, NJ 08854 ; 7325485700
• MDR Report Key: 3720885
• MDR Text Key: 4335116
• Report Number: 2250033-2014-00001
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2014

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: 04/30/2014
• Device Catalogue Number: DCJACT-A
• Device Lot Number: L2DCA036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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