MAUDE Adverse Event Report: ATRIUM MEDICAL OCEAN DRAIN; BOTTLE, COLLECTION, VACUUM

Model Number	2002-400
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received stated that after wall suction was connected to the drain the fluid from the chamber was drawn into the suction tube.
Additional Manufacturer Narrative
The drain was not returned for evaluation.Several attempts were made regarding the return of the drain without any success.Based on the details of the complaint it would appear that the suction may have been set too high at the source and/or the drain had reached its full capacity and had gone unnoticed.This cannot be confirmed, as no additional details regarding the event have been obtainable.A full review of the device history records was conducted and this lot of chest drains passed all quality and performance requirements.Based on the investigation of the details that were provided, atrium medical corporation cannot conclude that the ocean chest drain malfunctioned in anyway.Clinical evaluation: the ocean chest drainage system is indicated for the evacuation air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.The instructions for use (ifu) state to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and that patient tube connections, water seal, and suction control chamber should be checked regularly to confirm proper operation.The ifu also instructs to slowly increase suction to attain gentle bubbling.
Event or Problem Description
N/a.

• Brand Name: OCEAN DRAIN
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8033700
• Report Number: 3011175548-2018-01247
• Device Sequence Number: 19213858
• Product Code: KDQ
• UDI-Device Identifier: 00650862100211
• UDI-Public: 00650862100211
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2020
• Device Model Number: 2002-400
• Device Catalogue Number: 2002-400
• Device Lot Number: 425671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention