MAUDE Adverse Event Report: ARGON CRITICAL CARE PTE LTD BD DTXPLUS DT 4812

Model Number 682000

Device Problem Burst Container or Vessel (1074)

Patient Problem Blood Loss (2597)

Event Date 03/01/2014

Event Type  malfunction  

Manufacturer Narrative

Failure analysis was conducted to identify the cause.Evaluation methods employed included visual inspection of returned device, documentation and internal manufacturing process review.From the failure investigation and available information on the reported incident and since the returned kit was confirmed to be meeting the specification and fully functional, the cause of the complaint could not be determined as the actual complaint sample was not returned for investigation.There was no defect found on the returned unused samples.Since the returned devices were functional, no action will be taken.Argon will continue to monitor similar customer complaints and other input sources for potential trends and take the necessary action.

Event Description

Line blows out causing blood loss.Would have been fatal if not caught.This happened multiple times and the complainant were told happened during last medical mission to (b)(6).

• Brand Name: BD DTXPLUS DT 4812
• Manufacturer (Section D): ARGON CRITICAL CARE PTE LTD
• Manufacturer Contact: 198 yishun ave. 7; singapore 76819-6 ; 36311
• MDR Report Key: 5407078
• MDR Text Key: 37439066
• Report Number: 8020616-2016-00001
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 682000
• Device Catalogue Number: BD DTXPLUS DT 4812
• Device Lot Number: 105109
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other