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

Model Number DCJPT-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on 07/29/2016 references accriva diagnostics' complaint number (b)(4).Method codes: actual device not evaluated.No dhr review was required because the complaint is unrelated to product performance or packaging.Results code: no results available since no evaluation performed.Conclusion codes: human factors issue.Device not returned.Accriva has requested all data required to complete form fda 3500a.

Event Description

A healthcare professional reported that an end user sustained a cut to her hand while dispensing a directcheck quality control for a hemochron signature elite and pt/inr 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 when reconstituting the product had used the protective sleeve provided with the product.The injury was caused by a glass shard that protruded through the dropper vial after the protective sleeve was removed.No significant blood loss or other medical complications were reported.

• Brand Name: HEMOCHRON JR. DIRECTCHECK, 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: 5835260
• MDR Text Key: 50816313
• Report Number: 3002721930-2016-00009
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2016

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: Nurse
• Device Expiration Date: 01/31/2017
• Device Model Number: DCJPT-A
• Device Catalogue Number: DCJPT-A
• Device Lot Number: J5DPA006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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