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

Model Number	2002-000
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
The nicu staff at (b)(6) hospital attempted to hook-up the ocean water seal chest drain today.The seal would not work despite several attempts by different nurses and providers checking the set-up.A second drain from a second lot number was opened and the same issue occurred.After a third drain was used, a seal was maintained.No adverse outcomes occurred.
Additional Manufacturer Narrative
Additional information: d 10.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The details provided indicate that the water seal would not work despite several attempts by different nurses and providers checking the set-up.Upon removing the returned drain from the shipper box there was no noticeable damage to the drain and the water seal had been filled to the 2cm mark in the water seal chamber.There was a small amount of fluid in the suction control chamber.The drain appeared to be in good condition.There was a clamp already in position and clamping off the patient line.A vacuum was applied to the vacuum line and rapid bubbling was noted only in the suction control chamber as expected as the patient line was clamped off.There was no bubbling in the water seal.When the clamp was removed from the patient line the bubbling was noted in both the water seal and flow control chamber.This is considered proper operation of the drain.If the patient line was clamped off and there was still bubbling in the water seal chamber this would indicate that there was a leak somewhere in the system.This was not the case.A review of the device history records did not indicate that there were any non-conformances during the manufacture of the product and the product met all quality and performance criteria.Based on the details of the complaint and the testing of the returned product the reported complaint cannot be confirmed.The drain functioned and operated properly when tested.

• Brand Name: DRAINS OCEAN SINGLE
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11302829
• Report Number: 3011175548-2021-00163
• Device Sequence Number: 584559
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2021

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 Expiration Date: 05/21/2022
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Device Lot Number: 445526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/25/2021; 10/20/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/26/2021; 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Weight: 2