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

Model Number 3600-100

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The drain was opened and the or technician noticed a hair on the drain.

Manufacturer Narrative

The oasis chest drain was returned and removed from the large bio-hazard bag that the drain was packaged in.Upon opening the bag the large outer packaging of the drain had removed from the chest drain.The drain itself was still in the outer packaging but placed in the backward position with the tube set facing outward.For the drain to be in this position it would have been completely removed from the outer packaging.The hair was found on the top of the patient tube set and was taped in place by the institution.The hair was 3 inches long and brown in color.The details of the drain indicate that the hair was noticed when the drain packaging was opened.Unfortunately because the drain has been opened there is no way to confirm that the hair was introduced prior to the final packaging sealing operation or if it was introduced in the field when the drain was opened.A review of the manufacturing procedure mp009256 rev ad ( suction nozzle tag and tray insertion, chest drains) shows that there is a 100% inspection conducted for particulate and foreign matter during the process of packaging the chest drain into the tray.Hair is not allowed per the procedure.A review of the scrap reason codes within the device history records also show that there were no finished chest drains rejected due to hair being found prior to packaging.The production lot size for the oasis chest drain build was 3,510 individual units.Conclusion - based on the investigation atrium medical corporation cannot conclude that the hair was present in the package prior to the institution opening the sealed pouch of the chest drain or fell into the drain upon opening the sealed pouch at the institution.All chest drains are manufactured and packaged within a clean room environment where all efforts are made to ensure that the chest drains are clean and free of loose fibers or hairs.The procedure for gowning prior to entering the clean room requires all staff members to be suited in a one piece full body gown with two separate bouffant caps that cover all hair and beard covers if required and full foot coverage booties.

• 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: 9656525
• MDR Text Key: 190341838
• Report Number: 3011175548-2020-00204
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 451998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 105