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

Model Number 3650-100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 12/30/2016

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 during operation of a drain it was noticed that blood was leaking onto the floor and on front of drain.

Manufacturer Narrative

The returned unit had a significant amount of blood collection still in the unit.The lower right corner of the drain cover showed evidence of cracking and white stress marks.All units go through an automated leak test as part of the manufacturing process.Throughout the process the units go through several areas of visual, final packaging and quality control sampling inspections.The stress marks and cracking are evidence of damage that most likely occurred during shipping or handling of the unit once it was fully packaged.The instructions for use (ifu) states in the precaution section "do not use if package is damaged." summary/conclusion: the device history records indicate that this drain manufacturing lot met all acceptance criteria including the chest drain body and pressure testing.The unit had cracks and stress marks on the cover in the area of the leak, which indicates a significant amount of force was applied to that area either during shipping or handling at the facility.

• Brand Name: DRAIN, DRY TOTAL RECOVERY W/AC
• Type of Device: OASIS BRU DRAIN
• 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: 6289887
• MDR Text Key: 66162291
• Report Number: 1219977-2017-00016
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/09/2019
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Device Lot Number: 245001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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
• Patient Outcome(s): Required Intervention