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

Model Number	2002-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Physician called complaining that the ocean drain was set up incorrectly.There was no water in the water seal and the water column for suction control was not bubbling.The icu and operating room staff had been trained that morning on the drain.In spite of the training the drain was still set up incorrectly.The sales rep and the physician corrected the issue with suction and water seal and everything worked properly.Additional training was conducted for the icu staff.The surgeon was satisfied and the patient seemed to be doing well with no adverse events.
Additional Manufacturer Narrative
A sales representative reported that a physician called complaining that the drain was set up incorrectly.There was no water in the water seal and the water column for suction control was not bubbling.The icu and operating room staff had been in serviced in the morning on this drain due to the global back order on the express drains.In spite of this training, the drain was still set up incorrectly.The sales representative visited with the physician at the bedside.They corrected the issue with suction and water seal and everything worked correctly.In addition there was more training conducted for the icu staff.The surgeon was satisfied and the patient seemed to be doing well with no adverse events.The device was not returned, and no images were provided of the incorrect setup, therefore the complaint cannot be confirmed.Based on the provided details from the complainant, the nurse had failed to add water to the water seal and water suction column, and this is the reason the drain was not performing as intended.Once water was added, the drain functioned properly.The instructions for use provided with the drain aw011481 revision aa state the following in regards to the setup of the drain: step 1.Fill water seal to 2 cm line ¿ hold funnel down and fill to top.Raise funnel to fill water seal to 2 cm fill line.For models available with sterile fluid, twist top off bottle and insert tip into suction port.Squeeze contents into water seal until fluid reaches 2 cm fill line.Step 2.Fill suction control chamber to desired pressure level ¿ remove vent plug, pour water to desired suction level.Replace vent plug.The instructions are clear on how to fill the water seal as well as the suction control chamber and are the first two steps of the drain set up process.An additional iconic label is affixed to the back of each drain for easy set up.The iconic label clearly shows the user the proper method of filling the water seal as well as the suction control chamber.A device history record review could not be conducted, as the product lot number in question was not provided.Based on the details provided the chest drain had been set up improperly.The instructions are clear on how to fill the water seal as well as the suction control chamber and are the first two steps of the drain set up process.An additional iconic label is affixed to the back of each drain for easy set up.The iconic label clearly shows the user the proper method of filling the water seal as well as the suction control chamber.Based on the provided information the root cause is user error.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.H3 other text: device not returned.
Event or Problem Description
N/a.

• Brand Name: DRAIN OCEAN SINGLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12418948
• Report Number: 3011175548-2021-00909
• Device Sequence Number: 4815126
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT PROVIDED
• Patient Sex: Unknown