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

Catalog Number DCJCPT-N

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Healthcare professional reports that an end user was cut on the top of her left thumb when squeezing the direct check quality control vial.The user was not using the provided protective sleeve at the time of the incident.The affected area was disinfected.Initial blood test results for hiv and hcv were negative.There was no report of serious injury.During follow up communications, the customer reported that the lab assistant's finger healed nicely.

Manufacturer Narrative

(b)(4).Conclusion - human factors issue.End user was not using the protective sleeve at the time of the injury.The directcheck 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.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORPORATION; edison NJ 08820
• Manufacturer (Section G): INTERNATIONAL TECHNIDYNE CORP.; 23 nevsky st.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 20 corporate place south; piscataway, NJ 08854 ; 7325485700
• MDR Report Key: 3856474
• MDR Text Key: 4660971
• Report Number: 2250033-2014-00003
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/27/2014

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: 05/31/2015
• Device Catalogue Number: DCJCPT-N
• Device Lot Number: K3DNC011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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