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

Model Number 3600-100

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated there was a hair that was found in the packaged drain.

Manufacturer Narrative

As the oasis chest drain was not returned a thorough investigation could not be performed.There was also no image provided of the hair that was found within the package.A review of the manufacturing packaging procedure shows that there are two 100% inspections conducted for particulate during the process of packaging the chest drain.The first 100% particulate inspection conducted is during the blue csr wrapping process and the second 100% inspection is conducted just prior to the pouching sealing process.Based on the details within the inspection process hairs of any kind are not allowed.A review of the scrap reason codes within the device history records also show that there were no devices reject during the manufacture or inspection of the oasis chest drain lot in question for hair being present in the packaging materials.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 pouch 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.Clinical evaluation: the oasis chest drain 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 post-operative collection and re-infusion of autologous blood from the patient¿s pleural cavity or mediastinal area.If foreign material is introduced into an operative site the patient may experience a foreign body or host tissue reaction, infection, pain, and/or allergic reaction or toxicity.Foreign material that is discovered in the product packaging may cause a procedural delay if noticed during set-up.The instructions for use (ifu) state that the oasis drain is packaged sterile, or is packaged in a sterile fluid path format (only the contents of the sterile patient tube pack can be entered into the sterile field).The ifu also states do not use if device or package is damaged.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7975364
• MDR Text Key: 124331263
• Report Number: 3011175548-2018-01194
• 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: 10/17/2018

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: 06/28/2021
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 432443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1