MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD DTX; PRESSURE MONITORING KIT

Catalog Number 689111

Device Problems Device Reprocessing Problem (1091); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2016

Event Type  No Answer Provided  

Event Description

Leakage from zeroing stopcock during use.The cock lever was at off (90 degree) position.It was confirmed that blood residue on the bottom the stopcock lever.The hospital reported that they haven't done unusual handling causes blood goes to zeroing stopcock.

Manufacturer Narrative

Visual examination of the returned sample found that the zeroing stopcock lever located at non-detent position.No damage component found on the returned kits.The batch documents have been reviewed and the records showed that no problem was found relating to any visual defects during the manufacturing process.The review confirmed that all the operations, materials and tests were performed per manufacturing procedures.Based on the analysis and evaluation, the cause of leakage described above is likely due to the lever was not in the exact ¿off¿ position.This resulted a gap between the stopcock body and the lever.The seal between the two parts hence become not effective and caused leakage.

• Brand Name: DTX
• Type of Device: PRESSURE MONITORING KIT
• 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: 5503389
• MDR Text Key: 40794482
• Report Number: 8020616-2016-00014
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K935782
• 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,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 689111
• Device Lot Number: 510687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other