MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN; DRAIN SINGLE

Model Number	2002-400
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2017
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
Customer reported they noticed that the inner package of the chest drain was damaged, small slits were found in the inner package.Sterility could not be ensured.
Additional Manufacturer Narrative
The unit was received and inspected.The original packaging pouch was inspected for damage.The inspection was able to identify a 2.0mm tear on the front of the tyvek pouch.The remainder of the device packaging was inspected and no other damage was noted.A device history record review was performed and this lot of drains were found to have all specifications.It is unknown what type of transit and storage conditions the product saw after leaving atrium medical.There is no way to determine when the product was actually damaged whether it was possibly during shipping or related to handling/storage conditions, therefore the exact root cause cannot be determined.Clinical evaluation: the oasis chest drain is indicated for 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 post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.Damaged packaging may be the result of improper storage conditions or shipping occurrences.The instructions for use (ifu) states in precautions: do not use if device or packaging is damaged.

• Brand Name: OCEAN
• Common Device Name: DRAIN SINGLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6955622
• Report Number: 3011175548-2017-00188
• Device Sequence Number: 1221786
• Product Code: KDQ
• UDI-Device Identifier: 00650862100211
• UDI-Public: 00650862100211
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/17/2017

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: Other
• Device Expiration Date: 04/21/2020
• Device Model Number: 2002-400
• Device Catalogue Number: 2002-400
• Device Lot Number: 250024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1