MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS DIRECTCHECK QUALITY CONTROL; PLASMA, COAGULATION CONTROL

Model Number DCJACT-N

Device Problems Material Fragmentation (1261); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Dhr review was not performed as the complaint is unrelated to product performance or packaging.Results: no results available since no evaluation performed.Conclusion: human factors issue.Training deficiency.Device not returned.Review of this case determined that the end user had not been fully trained on the proper method to crush the directcheck act plus normal control vial.Accriva diagnostics has requested all data required for form 3500a.

Event Description

Healthcare professional reported that an end user punctured her finger while attempting to activate a directcheck act plus normal control.This control is packaged in a crushable vial containing a glass ampule.The end-user was wearing gloves, but was not utilizing the protective sleeve provided to safeguard against potential user injury during reconstitution.When crushing the vial, a glass shard protruded through the vial and caused the injury reported.No significant blood loss, complications or other medical issues were reported.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• 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: 5321414
• MDR Text Key: 34922024
• Report Number: 3002721930-2015-00010
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2015

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: 08/31/2016
• Device Model Number: DCJACT-N
• Device Catalogue Number: DCJACT-N
• Device Lot Number: C5DNA007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2015
• 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