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

Model Number	2012-320
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Chest tube fluid in suction chamber was clear and not dyed blue.No injury to patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: as the device in question was not returned a thorough investigation of the physical product could not be conducted.The product lot number was also not provided, as such a review of the device history records could not be conducted.An image showing two chest drains was provided by the institution.The first image of the drain has a higher level of blue tint as compared to the image of the second drain.It is possible that the fluid on the second drain had evaporated to a level that required more fluid to be added thinning the amount of tint in the water column.Without the drain in question this cannot be confirmed.It is also important to note that even if the water is not blue the chest drain will perform properly.During the manufacture of the chest drain the manufacturing operator assembles the internal components of the chest drain.The operator has to manually place each component and verify its presence before moving to the next chest drain in sequence.The manufacturing procedure requires that the operator also verify the presence of each component following manufacturing procedures.The dye plug in this instance is inspected for its presence in the drain at two separate operations in manufacturing.A review of the sales of the ocean drain over the last three years shows that there have been over 1 million ocean drains manufactured without a complaint for the dye not being present in the vacuum water control chamber other than from this institution.Summary/conclusion: based on the details of the complaint atrium medical corporation cannot conclude the ocean chest drain was faulty.It is possible that the water had evaporated over time requiring additional water to be added to the water column.If this was the case it would explain why the water was not as blue.

• 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: 10035029
• Report Number: 3011175548-2020-00635
• Device Sequence Number: 19612185
• Product Code: KDQ
• UDI-Device Identifier: 00650862101027
• UDI-Public: 00650862101027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2020

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: 2012-320
• Device Catalogue Number: 2012-320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1