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

Model Number 2012-320

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Chest tube fluid in suction chamber was clear and not dyed blue.No injury to patient.

Event Description

N/a.

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
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10035029
• MDR Text Key: 190322217
• Report Number: 3011175548-2020-00635
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862101027
• UDI-Public: 00650862101027
• Combination Product (y/n): N
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2012-320
• Device Catalogue Number: 2012-320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1