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

Model Number	4000-100N
Medical Device Problem Codes	Use of Device Problem (1670); Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Report received stated that after connection of an express drain it was noted that there was no water in the air leak chamber (c).The suction was turned off and the chest drain clamped, water was then added to (c) and it was then noticed that there was fluid near the regulator (e) of the drainage system.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction: the customer reported that after setting up the drain on a patient, they noticed the water seal chamber had no water in it.They clamped the patient tube and added water to the chamber.They then noticed that there was fluid in the bellows chamber.They reported this as a potential internal leak.The product was returned for evaluation and no evidence of an internal leak could be found.The welding around the bellows chamber was inspected and no defects were identified.The complaint could not be confirmed.A dhr review was completed and no nonconformances in manufacturing were identified.A review of relevant procedures and equipment was also completed and nothing was identified that is suspected to have contributed to the complaint.The ifu for this device provides instructions for how to set up and position the drain correctly.It is suspected that these instructions were not strictly followed (the drain was not kept upright at all times during use).The complaint trending review did not identify any excursions.The complaint history review found one related complaint, in which fluid was noticed in the bellows chamber.It was concluded in that complaint that the drain had been knocked over.A review of cars/capas was completed which identified one car resulting from a complaint of an internal leak in the collection chamber.The drain was evaluated and the complaint could not be confirmed.It was suspected that the leak resulted from a knock over.

• Brand Name: DRAINS EXPRESS SINGLE
• 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: 12312880
• Report Number: 3011175548-2021-00831
• Device Sequence Number: 4815540
• Product Code: KDQ
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 02/10/2024
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 467851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/02/2021; 09/15/2022
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/23/2021; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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