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

Model Number 3600-100

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hospital reported they had a device leak on set-up.When investigating they observed a crack on the drain body.

Manufacturer Narrative

A review of the returned drain confirmed the presence of a large crack in the lower front panels of the drain.A crack of the drain of this nature could only be caused by a very blunt force applied such as a drop of the drain or shipping and handling damage.The drains during the process of manufacturing undergo a full system pressure test to ensure the integrity of the drain.A crack of this nature would have easily been detected and rejected by the automated system.This crack is also large enough that the manufacturing operator would have been able to visually see the crack as well.A review of the device history records indicates that the lot of chest drains passed all quality and performance requirements prior to being released.The instruction for use state "do not use if device or package is damaged".Summary/conclusion - based on the results of the investigation the most probable root cause of the cracked oasis chest drains 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.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 9744054
• MDR Text Key: 186841063
• Report Number: 3011175548-2020-00316
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 452818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Date Device Manufactured: 12/02/2019
• 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