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

Model Number 2002-000

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Report received stated that an ocean water seal chest drain did not provide the proper pressure for the chest tube.A second drain from a second lot number was opened and the same issue occurred.

Manufacturer Narrative

Based on additional information received this complaint is a duplicate of a complaint already in the system.Reference mdr 3011175548-2021-00164.

Event Description

Based on information received this complaint was a duplicate complaint already reported.

• Brand Name: DRAINS OCEAN SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11503488
• MDR Text Key: 242433669
• Report Number: 3011175548-2021-00324
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• 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: 03/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Device Lot Number: 452015
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/11/2021
• Patient Sequence Number: 1