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

Model Number	2002-000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
Event or Problem Description
Report received stated that the drain was being used for a procedure and it started leaking.
Additional Manufacturer Narrative
Investigation: as the drain that was leaking was not returned an investigation into if the drain was leaking is difficult to determine.There was an image of the drain provided that shows a small crack in the lower left corner.There does not appear to be any traces of fluid within the collection chamber of the drain.Based on this it is not clear how the leak was noticed.The damage seen in the image appears to be from handling.There were no pictures provided of the packaging materials to confirm this.The provided image shows a crack in the front panel of the chest drain.The crack is located in the lower left corner of the drain.It is difficult to see if the welded area of the front panel to the drain body has been compromised by this crack.Damage of this nature is indicative of handling or shipping damage after the product has left the site of manufacture.Device not returned.

• Brand Name: OCEAN DRAIN
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8521145
• Report Number: 3011175548-2019-00399
• Device Sequence Number: 11435265
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1