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

Model Number DCJCPT-A

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr submitted on 05/03/2017 references accriva diagnostics' complaint number (b)(4).(b)(4).

Event Description

Healthcare professional reported that an end user sustained an injury while dispensing a directcheck quality control.This control is packaged in a glass ampule inside a crushable plastic dropper vial containing diluent.When reconstituting the control, the end-user wore gloves but failed to utilize the protective sleeve provided with the product.The purpose of the sleeve is to safeguard the end user against potential injury while handling the control.The end user squeezed the vial and sustained a small cut to her right thumb pad which was caused by a piece of glass piercing the wall of the vial.The end user washed the affected area with soap and water and applied a band aid.No further medical attention was sought and no complications were documented.

• Brand Name: 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: 6541341
• MDR Text Key: 74319425
• Report Number: 3002721930-2017-00009
• Device Sequence Number: 1
• Product Code: GGN
• UDI-Device Identifier: 10711234107065
• UDI-Public: 01107112341070651718013110M6DAC011
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: DCJCPT-A
• Device Catalogue Number: DCJCPT-A
• Device Lot Number: M6DAC011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• 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
• Patient Age: 30 YR
• Patient Weight: 88