MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAIN, DRY TOTAL RECOVERY W/AC; OASIS BRU DRAIN

Model Number	3650-100
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/30/2016
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 during operation of a drain it was noticed that blood was leaking onto the floor and on front of drain.
Additional Manufacturer Narrative
The returned unit had a significant amount of blood collection still in the unit.The lower right corner of the drain cover showed evidence of cracking and white stress marks.All units go through an automated leak test as part of the manufacturing process.Throughout the process the units go through several areas of visual, final packaging and quality control sampling inspections.The stress marks and cracking are evidence of damage that most likely occurred during shipping or handling of the unit once it was fully packaged.The instructions for use (ifu) states in the precaution section "do not use if package is damaged." summary/conclusion: the device history records indicate that this drain manufacturing lot met all acceptance criteria including the chest drain body and pressure testing.The unit had cracks and stress marks on the cover in the area of the leak, which indicates a significant amount of force was applied to that area either during shipping or handling at the facility.

• Brand Name: DRAIN, DRY TOTAL RECOVERY W/AC
• Common Device Name: OASIS BRU DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 6289887
• Report Number: 1219977-2017-00016
• Device Sequence Number: 1105772
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

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: Physician
• Device Expiration Date: 11/09/2019
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Device Lot Number: 245001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 02/20/2017
• 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