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)
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 the drainage is unable to reach the 200ml graduation mark on the drain.
Additional Manufacturer Narrative
Analysis: the actual drain for the incident was not returned.Two drains related to the incident were returned and evaluated.Once the drains were disinfected a 200ml beaker of blue colored water was poured into the first chamber of the drain through the patient tube line.Both of the drains filled appropriately to the 200ml mark without any fluid spilling into the next collection chamber.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: age or date of birth, sex, and weight.

• Brand Name: OCEAN DRAIN
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8393064
• Report Number: 3011175548-2019-00237
• Device Sequence Number: 2926619
• 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,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?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/26/2019; 03/31/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 03/29/2019; 04/03/2019
• 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