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

Model Number DCJLR-N

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

Healthcare professional reported that an unidentified end user sustained a superficial puncture wound to the skin of the finger when squeezing the directcheck act-lr normal quality control vial.The end user was not using the protective sleeve provided with the product to prevent potential injury when activating the control vial.The end use immediately washed the finger with soap and water and sought medical attention as per the hospital's standard operating procedure.No excessive bleeding occurred and no bandage was required.Per follow-up communication, the puncture wound has healed and the end user returned to work.

Manufacturer Narrative

Reference itc complaint #(b)(4).The directcheck protective sleeve is provided as a means to reduce probability of lacerations.Healthcare professional stated that the employee was not fully trained on the operation of the instrument.The entire staff was retrained as to how to run the controls and requirement to use protective sleeve.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.; edison NJ 08820
• Manufacturer Contact: jon mcdermed ; 23 nevsky st.; edison, NJ 08820 ; 8582632490
• MDR Report Key: 4546856
• MDR Text Key: 5524512
• Report Number: 2250033-2015-00001
• 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: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: DCJLR-N
• Device Catalogue Number: DCJLR-N
• Device Lot Number: H4DNL039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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