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

Model Number DCJLR-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Healthcare professional reported that an injury occurred to a quality control technologist during reconstitution of a directcheck quality control.This control is package in a crushable vial.The end-user was wearing gloves and was utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution.End-user sustained a small cut to the upper portion of the left thumb, which was caused by a glass shard protruding through the protective sleeve.The thumb was washed with soap and water, sanitized with alcohol and covered with a sterile bandage.The end user did not seek further medical attention.No significant blood loss occurred.Per follow-up communication, the puncture wound healed and the end user returned to work.There were no complications or other related medical issues.

Manufacturer Narrative

(b)(4).Method: dhr review was not performed as the complaint is unrelated to product performance or packaging.Conclusion: human factors issue.Training deficiency, device not returned.Review of this case determined that the end user had not been fully trained on the proper method to crush the direct check pt abnormal control vial.

• 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 ave; edison, NJ 08820 ; 8582632490
• MDR Report Key: 4665305
• MDR Text Key: 18092485
• Report Number: 2250033-2015-00003
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2015

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 Model Number: DCJLR-A
• Device Catalogue Number: DCJLR-A
• Device Lot Number: K3DLA042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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