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

Model Number	16400
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: complaint involves use of an express mini 500 (p/n 16400) in an outpatient setting, in which the sampling port reportedly became clogged due to attempts to empty the fluid collected.In these cases, the drain is set up on a patient by a clinician and then that patient is sent home with the drain where they are then responsible for its use and interpretation.This puts the responsibility of using the drain on a person who is not necessarily a trained medical professional with any knowledge of how to use and interpret the device.Sampling port clogged: this typically occurs when the user attempts to empty the drain with a syringe through the sampling (luer) port in order to extend the use of the drain.This can lead to collected fluid becoming trapped in the sampling port and solidifying, preventing future use of the port.This port is intended for clinicians to take samples of the drain fluid, not for routinely removing large amounts of fluid in order to extend the use of the drain.The ifu instructs the user to replace the drain when it becomes full.It also states that the use of the luer port is intended only for sampling patient drainage and that the user should not use the port or any other means to attempt to empty fluid from the collection chamber.In addition, the ifu states that "the express mini 500 is restricted for use in a healthcare facility.The express mini 500 should not be used for outpatient drainage." this type of complaint has been thoroughly investigated and is known to be cause by user error so further dhr review is not required to understand the issue.The ifu provides adequate instructions for the setup and use of the drain, as well as instructions about the intended users and environments.Outpatient use complaints of express mini 500 devices are confirmed.Device nonconformances of outpatient issues are not confirmed.The root cause of outpatient use complaints of express mini 500 complaints is user error.
Event or Problem Description
Report received stated that a patient called from her home stated the mini express 500 cd luer port is clogged.The patient has been home for several days after discharge from christian northeast.She and her husband have drained from the port with a syringe 3-5 times.She states it is now clotted and cannot be drawn from.The current fluid amount in the drain is about 300cc.She had an after-hour number for her care team at the hospital.I advise her to call them to advise them of the need for another chest drain.I also advised her to go to the nearest er if she could not contact them and resolve this today.She understands that the cd is not to be used at home and the need for this to be resolved before the cd fills.

• Brand Name: EXPRESS
• 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: 22201345
• Report Number: 3011175548-2025-000005
• Device Sequence Number: 7714026
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: (01)00650862164008
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K984496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: Other
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2025
• Initial Report FDA Received Date: 06/13/2025
• 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: Female