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

Model Number 3600-100

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Customer said that as they opened the drain to use on a patient, they noticed a very large crack on the left side of the drain.The drain was never used on a patient.

Event Description

N/a.

Manufacturer Narrative

The details provided indicate that the oasis chest drain had a very large crack on the left side of the drain that was noticed prior to use.As the oasis chest drain in question was not returned an evaluation of the physical product cannot be conducted.A review of the device history records indicates that the lot of chest drains passed all quality and performance requirements prior to being released.There were no rejected drains during the manufacturing of this lot for cracked or damaged drains.All drains are leak tested 100% in process.If a large crack was present during the time of manufacturing it would not have passed the leak test requirements.Based on the results of the investigation the most probable root cause of the cracked oasis chest drain is that the product was damaged while in transit.A large crack would have been noticed during the multiple manufacturing process steps in manufacturing including the 100% product leak test.Without the physical product or images of the device in question atrium medical corporation cannot confirm that the product in question was faulty.Device not returned.

• Brand Name: OASIS DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9520513
• MDR Text Key: 189989978
• Report Number: 3011175548-2019-01260
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 450885
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1