MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL; PLASMA, COAGULATION CONTROL

Model Number DCJCPT-A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on (b)(6) 2016 references accriva diagnostics' complaint number (b)(4).Actual device not evaluated.No dhr review was required because the complaint is unrelated to product performance or packaging.(b)(4).No results available since no evaluation performed.(b)(4).Human factors issue.Training deficiency.Device not returned.

Event Description

A healthcare professional reported that an end user sustained a laceration while dispensing a directcheck quality control for a hemochron signature elite and citrate pt microcoagulation system.This control is packaged in a glass ampule contained within a crushable plastic dropper vial containing diluent.The end-user was wearing gloves and was using the protective sleeve provided with the product when reconstituting the control.She removed the protective sleeve, squeezed the vial to dispense the control and a glass shard protruded through the dropper vial piercing the skin of her right index finger.Minor bleeding occurred.The end user washed her hand with soap and water and applied a bandaid to the injured area.No significant blood loss or other medical complications were reported.

• Brand Name: HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS; 6260 sequence drive; san diego CA 92121
• Manufacturer Contact: jon mcdermed ; 6260 sequence drive; san diego, CA 92121 ; 8582632490
• MDR Report Key: 6142730
• MDR Text Key: 61402053
• Report Number: 3002721930-2016-00016
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: DCJCPT-A
• Device Catalogue Number: DCJCPT-A
• Device Lot Number: H6DAC007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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