MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN

Model Number 3600-100

Device Problems Crack (1135); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Unit was returned and inspected for damage.There was a hole in the breather bag on the suction side of the drain.There was a large crack in the drain body on the patient line side of the drain.The csr sterilization wrap was not returned with the unit therefore it could not be inspected for damage.A device history record review was performed and the product was found to have met specifications.Drains are 100% leak tested with an automated system and then inspected by each operator as it progress down the production line.The amount of damage to the drain would not have passed the manual and automated inspection processes on the production line.The root cause appears to be that the damage was caused either by shipping or some type of impact.The instructions for use (ifu) states in the precaution section "do not use if package is damaged".

Event Description

Report received stated that there was a small hole in the plastic and sterile wrap packaging.Upon unpacking the drain a crack was noticed on the housing.Drain was not placed on the patient.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: OASIS DRY SUCTION WATER SEAL CHEST 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: 5838918
• MDR Text Key: 52177713
• Report Number: 1219977-2016-00170
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2016

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: Physician
• Device Expiration Date: 10/21/2018
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 229995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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