MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OCEAN SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number	2002-300
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Nurse found that the patient tube of the chest drain was detached from the chest drain unit during use, no bubble was found in suction control chamber though it is on suction drainage.Nurse then changed to another chest drain immediately, x-ray check up was done and the patient was fine.
Additional Manufacturer Narrative
Analysis: the ocean chest drain was returned.During the disinfection of the drain the patient line was easily removed from the patient line connection on the main body of the drain.Once the drain was disinfected it was dried.A small amount of alcohol was placed just inside the tube set.The tubing was then placed over the body of the drain line connection port.The tubing was then pulled upon repeatedly and the tubing would not come off.The drain line to the actual drain has a tensile strength requirement of 15lbs minimum.If this was exceeded during the activities surrounding the line being disconnected it is possible the seal was broken allowing bodily fluid to make its way into the connection.If this were the case, the bodily fluid acts like a lubricant allowing for an easy disconnection of the patient line from the body of the drain.During the manufacture of the drain the tubing is dipped in alcohol and pushed on to the drain connector.Upon drying the tubing creates a tight seal.On average the tensile strength of the drain line to the chest drain connector routinely exceeds over 20lbs of force.The ocean chest drain was set up per the instructions for use.The water seal chamber was filled to the proper 2cm fill line per the instructions for use.The drain was filled with water just above the 160ml line as it was with the plural fluid before it was decontaminated.The drain was then placed under vacuum.The wall vacuum pressure was set above -80 mmhg.Upon applying the vacuum the drain functioned properly without any abnormalities.The drain was operating properly.Conclusion: based on the results of the investigation and the details provided, atrium medical corporation cannot conclude that the device was at fault.

• Brand Name: DRAINS OCEAN SINGLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8842067
• Report Number: 3011175548-2019-00820
• Device Sequence Number: 2361489
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other