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

Catalog Number DCJLR-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

Healthcare professional reports an end user was punctured on his right pointer finger, distal joint when squeezing the directcheck quality control vial.The end user was not using the protective sleeve and was not wearing gloves at the time of the incident.The affected area was allowed to bleed and was cleaned with soap and water.There was no report of serious injury or administration of medical treatment.Per follow-up communication, the end user advised the affected area has healed.

Manufacturer Narrative

This mdr submitted (b)(4) 2014 references itc complaint #(b)(4).Method: device history records reviewed and fond 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 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.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: eleanor fox ; 20 corporate place south; piscataway, NJ 08854 ; 7325485700
• MDR Report Key: 3739224
• MDR Text Key: 4275195
• Report Number: 2250033-2014-00002
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/14/2014

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: 03/30/2015
• Device Catalogue Number: DCJLR-A
• Device Lot Number: L3DLA044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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