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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Report received from a patient's wife called the emergency support line for assistance with an atrium express mini chest drain during use at home.During fluid removal, the syringe tip broke off in the drainage port.The patient attempted to remove the tip using needle-nose pliers but was unsuccessful.A picture reviewed showed a bent plastic piece inside the sampling port, likely due to the pliers.The patient denied any shortness of breath.No injury was reported.The patient was advised to visit the hospital to have the drain replaced.
Additional Manufacturer Narrative
Additional information section: h6 this complaint reports that an express mini 500 drain was being used in an outpatient setting.The report stated that while removing drainage from the "drainage port" the tip of the syringe broke off in the port.They attempted to remove the broken syringe tip with pliers but were unsuccessful.A picture was provided showing the broken syringe tip inside the luer port of the drain.The picture also shows that the drain had about 125 ml of fluid inside it at the time.The drain has notes written on it indicating that at one point it had been filled with about 320 ml.It is not known how long the drain was in use or how many times fluid was removed from the drain.This device was being used in an outpatient setting which it is not intended for.It is also not intended for the sampling port to be used to empty the drain.When it is used in that way, fluid tends to congeal and build up in the port.Typically, this results in the port becoming clogged.In this case, the user most likely failed to fully unscrew the syringe from the port before attempting to pull it out and the tip of the syringe broke off inside the port.It is not known what type of syringe was used, as syringes are not provided by getinge with the drains.A dhr review and recurring lot number query could not be conducted because the product lot number was not provided.No evidence was identified to suggest that this complaint is related to manufacturing, materials, equipment, or design.The ifu provides adequate instructions for the setup and use of the device.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 historical review of ncrs was completed and there were no related ncrs identified.There was a relevant related capa identified which relates to the express mini home use.A complaint history review did identify one similar complaint reported that the luer port broke when a home nurse attempted to remove fluid from the drain.It was determined that most likely the syringe tip had broken off and the root cause was user error due to misuse of the drain.This complaint is confirmed.A device nonconformance is not confirmed.The root cause of this complaint is user error due to misuse of the device.
Event or Problem Description
N/a.

• 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: 22563873
• Report Number: 3011175548-2025-000008
• Device Sequence Number: 3904050
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: (01)00650862164008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/04/2025

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: Lay User/Patient
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 77 KG