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

Model Number	2002-300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
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 the drainage is unable to reach the 200ml graduation mark on the drain.
Additional Manufacturer Narrative
Analysis: the drain in question was disinfected prior to testing as it was still full of pleural fluid.Upon completion of the disinfection a 200ml beaker of blue colored water was poured into the first chamber of the drains through the patient tube line.The drain filled to the 200ml line on the chamber as expected.There were no signs that the fluid was leaking over into the other chamber at the 180ml fill mark as described in the complaint details.A review of the device history records indicates that this lot of chest drains passed all quality requirements.Conclusion: based on the results of the investigation atrium medical corporation cannot conclude that there was any fault of the device.

• Brand Name: OCEAN DRAIN
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8393060
• Report Number: 3011175548-2019-00238
• Device Sequence Number: 19564740
• Product Code: KDQ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 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: 03/18/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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
• Patient Weight: 2