MAUDE Adverse Event Report: ATRIUM MEDICAL OCEAN DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number	2002-300
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2018
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 stated that a small hole was noticed in the packaging of the drain.
Additional Manufacturer Narrative
The unit was received and inspected.There was a small hole found in the tyvek portion of the chest drain pouch.The hole was located on the backside of the drain and was approximately 3mm long and 2mm wide.There were no other signs of damage to the chest drain or the blue csr wrap.A review of the device history records was performed, including the performance testing results of the product.This review has determined that there were no anomalies during the manufacture of the product.The product met all quality requirements.Review of the handling and distribution test that was conducted on the drain product found that there were no breaches of the sterile barrier during the testing.Based on the results of the investigation it is likely that the packaging of the chest drain was compromised after leaving the atrium medical manufacturing facility, possibly either during shipping or handling process.The ocean chest drainage system is indication for use the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.A package that is damaged would be noticed prior to admission to a sterile field.Damaged packaging may be the result of improper storage conditions or shipping occurrences.The instructions for use (ifu) instructs to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and to not use if device or package is damaged.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OCEAN DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7862738
• Report Number: 3011175548-2018-00999
• Device Sequence Number: 1964246
• Product Code: CAC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 02/13/2021
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 428202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1