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

Model Number	2002-300
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
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 that a suction tube was found missing when user opened the package.
Additional Manufacturer Narrative
The ocean chest drain was returned from the field and evaluated.Upon initial inspection the suction line assembly was not present with the drain confirming the complaint.Only the patient line tube set was present.A review of the device history records show that all parts were supplied and consumed for this production build of chest drains.The build quantity was 3,510 units.The device history records also show that the quality inspection confirmed the presence of the suction line on 50 individual units picked from the production line prior to packaging.There were no non- conformances noted during the build of this ocean drain lot.Based on the results of the investigation atrium medical cannot determine that the suction line was not present when the product was shipped.Clinical evaluation: the ocean chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use advise: "do not use if the package is opened or damaged".The device is supplied sterile and the packaging should be inspected prior to use to ensure it is intact and not damaged.
Event or Problem Description
N/a.

• 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: 8681121
• Report Number: 3011175548-2019-00639
• Device Sequence Number: 19406301
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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 Expiration Date: 09/04/2021
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 434464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1