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

Model Number	16400
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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
It was reported that upon opening express mini drain, it was identified that both drainage tubing and chest drain had male connectors.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: h6 corrected fields: d4(lot, udi), d9, h4.This complaint reports that an express mini (p/n 16400, l/n 20649) was received with an extra male connector attached to the patient line connector.The customer provided pictures which showed a male connector in the patient line and another one in the female connector on the drain.Express mini drains are only intended to have one male connector and it is provided to the customer attached to the patient line and not to the drain.When tube set assemblies are received from the supplier, they have the entire connector (male + female halves) attached.During manufacturing, the female half of the connector is removed and set aside, leaving the male half on the drain.The patent tube with the male connector is placed in its own pouch.The female half later has a cap added to it and is attached to a 6-inch tube and then that subassembly is attached to the patient nozzle on the drain.Once the drain is fully assembled and placed in a packaging tray, a pouch with a patient tube assembly and male connector is placed on top of it.A final assembly could end up with two male connectors if the entire connector assembly is removed from the patient tube and attached to the 6-inch tube, and then a patient tube assembly that still has a male connector is added to that drain.The cap that is added to the female connector could hide a male connector if it was still attached so it would not be visually identifiable after that step.The drain was received back for evaluation without the patient tube.The drain did have a male connector attached to the female connector.The male half of the connector was able to be removed by pressing in the release button, as intended.No deficiencies were identified with the button or with the rest of the drain.A dhr review was completed which did not identify any anomalies during manufacturing.This nonconformance occurred during manufacturing and went undetected.An ncr query was completed for the relevant lots and none related to this complaint were identified.The ifu provides adequate instructions for the use of the device and is not related to this complaint.Complaint trending did not identify and adverse trends related to this complaint.No similar complaints were identified.No related ncrs, crs, or capas were identified.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.This complaint and device nonconformance are confirmed.An additional male connector was included in an express mini final assembly.It was determined that if an error is made in the manufacturing step where the male and female halves of the connector are separated, this would most likely not be noticed in later steps and therefore this is most likely where the error occurred.The root cause of this complaint is manufacturing - assembly.This complaint required escalation to a corrective action request therefore (cr 1422525) has been initiated.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: e1- event site telephone.

• 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: 23389484
• Report Number: 3011175548-2025-000011
• Device Sequence Number: 15944944
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: (01)00650862164008(17)280602(10)520649
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2025

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: Health Professional
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Device Lot Number: 520649
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 12/03/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/03/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: N/A.
• Patient Sex: Unknown