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

Model Number	3600-100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Suction Problem (2170); Material Split, Cut or Torn (4008); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of our investigation.
Event or Problem Description
Report received stated that an oasis chest drain had holes in the tubing.After hooking it to the patient and it was found that there were holes in the tubing.When they could not create suction, it was removed.There was no harm or patient injury, the drain was replaced and had no issues.
Additional Manufacturer Narrative
Additional information section: d9 & h6.This complaint reports that after attaching an oasis drain (p/n 3600-100, l/n 517802) to a patient, the user was unable to create suction and found holes in the tubing.The drain was replaced.The user stated that there was no harm to the patient.When additional information about the holes were requested, the user responded that there were actually no holes in the patient tube, but rather, the issue was a leak at the connection of the patient tube to the drain body.The device was returned for evaluation.Upon receipt, there was drained fluid spilled inside the packaging and throughout the drain.It is not known how much fluid the drain had collected because it was spilled during shipping, but it is clear that the drain was functioning to some degree.The patient tube was cut at the distal end and the end of the tube and the connector were not returned so they could not be evaluated.The device was cleaned and examined for holes in the patient tube.None were identified.The device was attached to wall suction and functioned properly.Water was poured through the patient tube into the drain and none leaked out at the tube connection.However, it was noticed that just below the patient tube nozzle, there is a crack in the drain body which could allow fluid to leak out of the drain.A dhr for lot 517802 was reviewed and no anomalies in manufacturing were identified.The ifu provides adequate instructions for the setup and use of the device.The ifu instructs the user to regularly check all the drain connections and not to use the device if it or the packaging is damaged.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found similar complaints.A recurring lot number report was completed for lot 517802 and no other complaints involving that lot were identified.An ncr query found no related ncrs.A cr/capa query found 1 related cr for past complaints of damaged drain bodies.The complaint is confirmed, as is a device nonconformance.The most likely cause of this complaint is supply chain - handling damage.Based on the confirmed nonconformance the complaint has been escalated to a capa request cr 1320069.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected section: h6 and h11.Based on further evaluation of the drain it was determined that what was originally believed to be a crack in the drain was instead the line where two haves of the drain body were joined together.This is an intended part of the drain and does not expose the internal chambers of the drain to atmospheric pressure.While the complaint remains confirmed, a device nonconformance can no longer be confirmed and the cause of this complaint cannot be determined.
Event or Problem Description
N/a.

• 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: 22065828
• Report Number: 3011175548-2025-000004
• Device Sequence Number: 7639096
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(17)280218(10)517802
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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: 517802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 08/18/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/03/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown