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

Model Number 3600-100

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Information (3190)

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 drains tubing is cracked and leaking which caused an air leak.

Manufacturer Narrative

The unit was not returned for evaluation therefore an investigation as to the cause could not be confirmed.The report stated the tubing was cracked.The tubing used in the manufacturing of the drains is a thermoplastic elastomer that is very flexible and resistant to cracking.All drains are automatically tested for leak and regulator function during the assembly process.Visual inspections are conducted by each operator in sequence to ensure all components are present and acceptable.Without having the actual product for investigation it is difficult to determine root cause of the reported complaint.It is possible that the unit itself was damaged during shipping 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: 5949402
• MDR Text Key: 54674900
• Report Number: 1219977-2016-00199
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• 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