MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100 - DRAIN DRY SINGLE W/AC

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.Device not returned.

Event Description

Received report of a hole in packaging and wrap of oasis dry suction water seal chest drain hole was noted by circulating nurse prior to being placed on sterile field.Hole was found at corner.Device was not used.

Manufacturer Narrative

A full review of the device history records was conducted.The review indicates that this lot of chest drains met all quality and performance criteria.As the device in question was not returned a root cause cannot be determined.If the drain were returned it would have been evaluated to determine the cause of the complaint and to confirm the package was damaged as stated in the complaint details.Clinical evaluation: the oasis chest drainage system is indicated for the 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 postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.A package that is damaged would be noticed prior to admission to a sterile field.Damaged packaging may be the result of improper storage conditions or shipping occurrences.It would represent a delay in treatment for the patient.The instructions for use (ifu) 3 states the oasis drain is packaged sterile and do not use if device or package is damaged.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8949301
• MDR Text Key: 156106763
• Report Number: 3011175548-2019-00924
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: 06/24/2022
• Device Model Number: 3600-100 - DRAIN DRY SINGLE W/AC
• Device Catalogue Number: 3600-100
• Device Lot Number: 448176
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1