MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; BOTTLE, COLLECTION, VACUUM

Model Number	3600-100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oasis drain did not function after being connected to the patient.The icc site and dressing were intact.Staff replaced the unit, and the new drain worked properly.There was no patient harm reported.
Additional Manufacturer Narrative
As per the information provided, the lot number involved in the event could be either 522742 or 521004.Hence the information for both the lot numbers are captured in the report.Due to character restrictions the information for 2nd lot number: d4: lot: 521004.Exp date: 30 jul 2028.Udi: (b)(4).H4: mfg date: 1 aug 2025.Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: h6.The customer reported that an oasis drain when connected to the patient was not draining.Upon observing that the drain was not draining the staff checked the icc site and the dressing was sealed and intact.The staff replaced the unit with another, and it began draining, so it appeared the unit may be at fault.The faulty unit did not have any visible damage, and they were not able to determine exactly where the leak/fault was.No reported harm came to the patient.The chest drain in question was returned and evaluated.The drain was thoroughly inspected visually to determine if there had been any damage to the drain.No damage was noted during this inspection.The chest drain was then hooked up to the vacuum leak tester and it was noticed that the water seal of the drain was not filled to the proper fill level.Additional water was added to the water seal through the suction port as instructed in the instructions for use (ifu).The drain was placed under vacuum at greater than -80 mmhg as indicated within the ifu.The suction line was placed over the suction port of the returned drain and bubbling in the water seal area was observed as expected.The patient line of the drain line was then blocked.The bubbling in the water seal stopped.This indicates that the drain is fully sealed and not leaking and is the expected result.A leak of the returned drain cannot be confirmed.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review did identify several related complaints involving leaks or lack of suction however none were confirmed to be the fault of the manufacturer.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.Based on the provided details it is possible that the patient line where it is attached to the chest drainage catheter may have been leaking and was resolved when disconnected to change out the drain.There is also a possibility that the chest tube catheter was not placed optimally and during the replacement of the drain was moved enough to begin collecting appropriately.It is not clear why there appeared to be a leak, however the returned drain was fully functional.The root cause is impossible to define as the drain in question that was returned was found to be not leaking and conforming in regard to drain performance.It is likely that the connection between the patient line tube to the catheter was leaking or there was a leak where the catheter enters the patient as an airtight seal is required here as well.

• Brand Name: OASIS
• 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: 24232877
• Report Number: 3011175548-2026-000001
• Device Sequence Number: 8971511
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(10)522742(17)280815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 522742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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: UNKNOWN.
• Patient Age: 18 YR
• Patient Sex: Female