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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the suction port of oasis drain seems to be collapsing and impacting the suction.There was no adverse event reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6) medical center.Event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Additional field: h6.Customer reported that the oasis drain suction port seems to be collapsing and impacting the suction.Based on the details provided as well as the image located in the attachments the suction nozzle has been damaged at some point after leaving the site of manufacturing.The first step when setting up the drain for use is to remove the pre-filled ampule from the back of the drain and remove the cap and squeeze the contents into the suction port of the drain.Based on the image of the drain this would not have been able to be conducted as the nozzle appears to be melted and crushed.The drain seen in the image would have clearly been noticed when preparing the drain by filling the water seal with the provided water ampule by the user.The images also show that the drain was collecting fluid at some point during the procedure.Once the water from the supplied ampule is added into the suction port and water seal the suction source tubing from the hospital is placed over the suction port and during this process any damage to the suction port would be noticed.During the process of manufacturing the suction nozzle is hand placed onto the drain unit by the manufacturing operator who then welds the suction nozzle into place.Once completed the nozzle weld is inspected to ensure the nozzle has been welded properly.This is conducted by the operator placing their thumb on the tip of the nozzle and applying steady pressure.A nozzle in this condition would have been self-evident during the inspection process.Although the damage has been confirmed there is no evidence to support that the product was manufactured in this condition.There had recently been a similar complaint where the nozzle had been damaged.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 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.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 one recent complaint which had similar reported damage to the suction nozzle.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: 24032143
• Report Number: 3011175548-2026-000000
• Device Sequence Number: 9260382
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/20/2026
• 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: UNKNOWN.
• Patient Sex: Unknown