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

Model Number	2002-000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Pt with 2 chest tubes (ocean) to -20 suction s/p thoracotomy.Pt did not have air leak previously, but noted continuous bubbling in air leak chamber.Collection tubing was clamped and air leak still showing as present.Connections checked and tightened/no visible holes in tubing.Air leak remained issue so drain was swapped out and no air leak present with new drain.
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The customer reported that an ocean single collection drain was set up on a patient.The patient had a second drain connected to them at the same time.The patient did not have an air leak prior to attaching the drain.Once the drain was set up, continuous bubbling was noted in the air leak detection chamber, even after the patient tube was clamped shut.The user checked all the connections and could not identify any holes in the tubing.The air leak persisted so they swapped the drain out for a new one, which did not detect an air leak.The device was not returned to atrium and no pictures or lot number were provided.Possible causes of an air leak are a break somewhere on the body of the drain, a nonsecure connection in the tubing or holes in the tubing, or a leak originating from the patient.The user reported that they inspected their setup for insecure connections, damage, and for a leak from the patient (by clamping off the tubing) and could not identify the source of the air leak.Without the drain being returned or pictures or a lot number provided, a proper evaluation of the device cannot be performed.For these reasons, neither the complaint nor the device nonconformity can be confirmed.A dhr review could not be completed because the lot number was not provided.An eco history of the finished good specification was reviewed and did not find any past changes that would likely be related to this complaint.The ifu for this device provides adequate instructions for the setup and operation of the device and warns the user against several actions that could lead to device air leaks.It instructs the user to check all the connections regularly.A complaint history review was completed which identified one related complaint for which the root-cause was determined to be operational context.Cars/capas were reviewed and a single related car was identified, however it was not escalated to a capa because there was no evidence of a product defect.There were no capas that were identified.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.Based on the information provided in the complaint and the results of the investigation, it could not be confirmed that there are any nonconformities with the device.The cause of the air leak cannot be identified and there are many potential causes originating from the setup of the device or the condition of the patient.The root-cause of this complaint is impossible to define.H3 other text : device not returned.

• Brand Name: DRAINS OCEAN 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: 15139255
• Report Number: 3011175548-2022-00214
• Device Sequence Number: 17546498
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 02/16/2023
• 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