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

Model Number 2002-300

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that the drainage is unable to reach the 200ml graduation mark on the drain.

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
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8393060
• MDR Text Key: 137923955
• Report Number: 3011175548-2019-00238
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 2