MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 the drain had a broken part found when package was opened.

Manufacturer Narrative

The returned unit was received and visually inspected.The drain was found to have a broken clip on the in-line connector.The in-line connectors are attached to the tube assembly per manufacturing assembly procedures.Visual inspections are conducted by each operator in sequence to ensure all components are present and acceptable.The most likely root cause appears to be the unit sustained either shipping damage during transport and/or handling.

• Brand Name: OASIS DRAIN, DRY SINGLE W/AC
• Type of Device: OASIS DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6049636
• MDR Text Key: 58181197
• Report Number: 1219977-2016-00225
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

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: Other
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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