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

Model Number 3600-100

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/27/2016

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 during set-up the drain was observed to have a leak prior to use on patient.

Manufacturer Narrative

The complaint indicated that the unit leaked fluid during setup.During setup the only fluid the unit would have seen is what is added to the air leak monitor (alm) as part of the setup process.There was no fluid in the alm upon receipt, but the supplied water ampoule was missing and there was evidence (blue water spots) that the area had previously been filled.There was no evidence of water spots on the outside of the device that would indicate leakage from the alm.The returned unit was setup per standard instructions for use (ifu).Water was added to the alm using a standard water ampoule that is supplied with each oasis drain.The returned unit was left standing for 2 hours and no leaks from the alm were observed.The device history records indicate that this drain manufacturing lot met all acceptance criteria including the chest drain body and pressure testing.As the device in question met all quality and performance criteria and the device functioned properly when water was added to the alm with no leakage observed, atrium can find no fault with the device.

• 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: 6168592
• MDR Text Key: 62460801
• Report Number: 1219977-2016-00253
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2016

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: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 237926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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