MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD SAFEDRAW; SAFEDRAW SET

Catalog Number 688296

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 08/28/2014

Event Type  malfunction  

Manufacturer Narrative

A review of the batch documentation, which includes device history records and inspection reports, showed that no problem was found relating to damage stopcock and/or leakage during the manufacturing process.The affected kit assembly was manufactured in march 2014.From the failure investigation and available information on the reported incident, the possible cause of the complaint described above is due to combined effect from the following: presence of silicone oil or any fluid migrated at the interface acted as lubricant on the luer nut tightened to the female fitting and method of tightening the male luer fitting of the stopcock to the female luer fitting.The supplier has been notified regarding the complaint and took necessary corrective action and preventive actions.Defect awareness training was also conducted to the involved production associates of argon (b)(6).

Event Description

Used on patient.Blood leaked due to detachment of luer nut of white 3 way stopcock during procedure.

• Brand Name: SAFEDRAW
• Type of Device: SAFEDRAW SET
• Manufacturer (Section D): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD; 198 yishun avenue 7; 76892 6; SN 768926
• Manufacturer (Section G): ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD
• Manufacturer Contact: sylvia er ; 198 yishun avenue 7
• MDR Report Key: 5537004
• MDR Text Key: 41821614
• Report Number: 8020616-2016-00016
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2016

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: Other Health Care Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 688296
• Device Lot Number: 403264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1