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

Model Number	3600-100
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the oasis chest drain, it was found to be damaged.There was no adverse event or harm reported.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
It was reported that during use the oasis chest drain, it was found to be damaged.There was no adverse event or harm reported.
Additional Manufacturer Narrative
Additional section: h6.Corrected section: b3, b5.The customer reported that the critical care team opened a chest drain that was found to be damaged.Additional information provided stated that the drain was set up by an experienced charge registered nurse and that it was set up properly and was not defective at the time of set-up.Also provided was that the drain was in use when the defect was discovered.The information provided by the customer and the device evaluation confirm the complaint however the evidence in the complaint indicates that the damage occurred at the institution and not by the manufacturer.Based on the investigation results this complaint is related to user error as the damage occurred after the drain was set up for use.As part of the investigation the nozzle of the drain was sent to the getinge corporation analytical lab for material characterization using fourier transform infrared spectroscopy (ftir), and thermal analysis using differential scanning calorimetry (dsc), and thermogravimetric analysis (tga).These tests were conducted to determine if at some point after manufacturing did the nozzle melt.The results of the testing concluded the following: the ir spectra, melt temperatures (tm) and thermal degradation profiles were identical for control and complaint samples confirming that the bulk chemical composition of the abs material remains unchanged.In conclusion, the complaint nozzle (#(b)(4)) is chemically identical to the control nozzle.The loss of tg1 provides evidence that the material underwent significant localized heating and stress-induced thermal alteration during the crushing event." the full report from the analytical lab is attached to this complaint investigation.Based on the conclusion of the report it is apparent that the drain nozzle was melted at some point after the drain was set up by the user.A dhr review and recurring lot number query was unable to be conducted as the product lot number was not provided.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.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.A complaint history review was completed which found no similar complaints directly related to this complaint.The information provided by the customer and the device evaluation confirm the complaint however the evidence in the complaint indicates that the damage occurred at the institution and not by the manufacturer.Based on the investigation results this complaint is related to user error as the damage occurred after the drain was set up for use.

• 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: 23836608
• Report Number: 3011175548-2025-000013
• Device Sequence Number: 12029068
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown