MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. OCEAN DRAIN

Model Number 2020-300

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Rec'd report of three events of leakage with patient tubes where they could not control the leakage.

Manufacturer Narrative

At the time these events were reported to atrium the investigation revealed that these events were due to the user not following the instructions for use.The user was not clamping the unused line.The user has been provided with further explanation and pictures to help explain the correct setup of this unit.A review our complaints database shows that we have not had any similar reports of this nature, and no add'l reports from this reporter.The other two reports are: 1219977-2014-00067 and 1219977-2014-00069.

• Brand Name: OCEAN DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687996
• MDR Text Key: 4288990
• Report Number: 1219977-2014-00068
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2020-300
• Device Catalogue Number: 2020-300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2009
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention