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

Model Number 3600-100

Device Problem Crack (1135)

Patient Problem No Information (3190)

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.Related mdr: 1219977-2016-00227.

Event Description

Report stated that the drain was cracked.No further information was provided.

Manufacturer Narrative

The drain was received and visually inspected.The drain was found to have a crack in the lower left corner of the cover.This is indicative of damage incurred during shipping and/or handling.A device history record review was performed and the drain lot was found to have met all specifications.Drains are 100% leak tested with an automated system and then inspected by each operator as it progress down the production line.The damage/crack in the drain would not have passed the manual and automated inspection processes on the production line.The instructions for use (ifu) states in the precaution section "do not use if package is damaged".Engineering summary/conclusion: the root cause appears to be that the damage was caused either by shipping or some type of impact seen at the user facility.

• 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: 6049635
• MDR Text Key: 58531683
• Report Number: 1219977-2016-00226
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/12/2019
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 232948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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