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

Model Number	2002-000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated that the facility felt there was a possible air leak in the ocean drain even after checking connections, because they were unaware if bubbling was normal.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction to awareness date 22-mar-2022.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected data: initial report aware date for g3 should have been 03/25/2022.This complaint reports that the users had difficulty with ocean drains.They were unaware that bubbling in the suction control chamber is normal when suction is applied and believed that the patient had an air leak.Information obtained from gfe communications indicate that the team was utilizing both the oasis and ocean drains at the time and were confusing the operation of the two drains.They have decided to stop using ocean drains.No patient harm was reported.The report does not describe a device malfunction, just a misunderstanding by the user on how the device should behave.No device was returned for evaluation.No pictures were provided.No lot number was provided, thus, neither a contemporaneous nor a companion sample could be evaluated.No lot number was provided so a dhr review was not possible.No evidence has been identified to suggest that this complaint is related to manufacturing or design of the device.The instructions for use (ifu) provides adequate instructions for the setup and use of the device and contains all the information required to avoid this failure.There was no evidence that was found to suggest manufacturing was the cause of this complaint.The complaint reported that the user did not understand that bubbling in the suction control chamber is normal when suction is applied to the drain.No device nonconformities are alleged in this complaint.No evidence was identified in the review of trending, device design, or the instructions for use to suggest there may have been an issue with the device or ifu.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity has not been alleged by the complainant and has not been confirmed by the investigation.The root-cause for this complaint is user error.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.H3 other text : device not returned.

• Brand Name: DRAINS 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: 14075346
• Report Number: 3011175548-2022-00120
• Device Sequence Number: 12296456
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2023

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: 03/26/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 04/14/2023
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 04/21/2022; 04/17/2023
• 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
• Patient Sex: Unknown