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	12/28/2024
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
Nurse called reporting that she was in a patient's home and was attempting to empty an express mini 500 cd using the needleless luer port and a syringe.I reviewed with the nurse the off-label at-home use of the product and that it is recommended in the ifu that if needleless luer port becomes clogged, replace with a new device.She understands and thanks me for the information.Nurse stated they will be getting the patient to the er.The hospital care team did not send the patient home with another drain.Nurse does not wish to share any patient or personal information but does communicate which hospital discharged the patient to home.

• 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: 21158161
• Report Number: 3011175548-2025-000000
• Device Sequence Number: 15367714
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: (01)00650862164008
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: 16400
• Device Catalogue Number: 16400
• 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: 12/28/2024
• Initial Report FDA Received Date: 01/15/2025
• 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: Unknown