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

Model Number 3600-100

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

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 that upon opening the packaged drain it was noticed that the drain had a defect in the water seal fill port.

Manufacturer Narrative

The unit was received and inspected.The vacuum nozzle was badly damaged and the drain handle was also slightly damaged from blunt impact.The deformation seen on the nozzle is very obvious and the manufacturing operators would have easily seen this type of damage when placing the suction port label into the nozzle itself.A full review of the device history records of this production lot of drains could not be conducted as the product lot number was not provided.The investigation was able to confirm that the chest drain had most likely become damaged after leaving the atrium manufacturing facility.It is not known at what point the drain became damaged.Clinical evaluation: the oasis chest drain is indicated for evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.Damaged packaging may be the result of improper storage conditions or shipping occurrences.The instructions for use (ifu) states in precautions: do not use if device or packaging is damaged.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6960452
• MDR Text Key: 90533319
• Report Number: 3011175548-2017-00185
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• 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