MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

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

Device Problems Use of Device Problem (1670); Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

Laura an icu nurse called wanting clarification about where to insert the water when setting up the oasis drain.She said when she set one up last week there was a tag hanging out of the blue suction port with specific directions.However, today there was no tag, so she wasn't sure.She put the water in on the back in the grey port and wanted to know if it was ok before she attached it to the patient.The fluid was at the line, she just wanted conformation that was correct.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

N/a.

Manufacturer Narrative

Investigation summary: an icu nurse called the customer service team wanting clarification about where to insert the water when setting up the oasis drain.She said when she set one up the prior week there was a tag hanging out of the blue suction port with specific directions.However, with the oasis drain there was no tag, so she wasn't sure.She put the water in on the back in the grey port and wanted to know if it was ok before she attached it to the patient.The fluid was at the line, she just wanted conformation that was correct.The customer support representative reassured her that was fine.Based on the details of the complaint the individual who called had likely used an express chest drain prior to using the oasis chest drain.The express single chest drain finished good code number 4000-100n and 4050-100n express bru are both provided with an iconographic hanger tag label (p/n 010488 artwork, suction nozzle tag, syringe revision ab) instructing the user to not put the water in the suction nozzle and to fill the water seal chamber using the needless luer port on the back of the drain.This instruction is also provided within the instructions for use aw011992 ifu, drains, express, revision aa.The review of previous instructions for use show that the ifu had changed part numbers two other times since 2019.Ifu aw011483 and ifu aw011091 both have the same verbiage for set up with regards to adding water in step 4.¿step 4.Air leak monitor ¿ fill air leak monitor to fill line by syringe (no needle) with 30 ml of sterile water or sterile saline via the needleless luer port located on the back of the drain.Twist top off syringe and insert tip into needleless luer port.Depress and hold tip of syringe against needleless luer port and squeeze contents into air leak monitor until fluid reaches fill line.¿ this fill location for the air leak monitor is also provided on the back of the drain in an iconographic label ls000108 label, printed, drains iconographic revision ab express ifu label_03aug23.The iconographic labeling on the back of the drain has been in place since 2019 for both the express series of drains as well as the oasis series off chest drains.At the time of the call to customer service it appears that the user was now using the oasis chest drain.This model chest drain does not have a hanger label in the suction port and is likely the source of confusion.The oasis chest drain is filled at the location of the suction port.This instruction is provided on the iconographic label ls000108 label, printed, drains iconographic revision ab oasis ifu label_03aug23.A review of this label shows that the iconographic label has been in use since 2019 for all oasis product codes.The current instructions for use aw011991 ifu, drains, oasis revision aa state the following: "set up step 1.Fill water seal to 2 cm line ¿ add 45 ml of sterile water or sterile saline via the suction port located on top of the drain.Twist top off bottle and insert tip into suction port.Squeeze contents into water seal until fluid reaches 2 cm fill line." a review of the previous instructions for use aw011090 and aw011991 was also conducted.The verbiage has not changed for step 1 between the three separate instructions for use that cover the last 3 years that coincides with the shelf life of the product.Both the instructions for use and iconographic labeling on the back of the drain are very clear as to how to fill the water seal.Based on the complaint investigation and the details of the complaint, the user could have obtained the information from the iconic label on the back of the drain and/or the instructions for use if they were available.Based on this information the complaint has been confirmed as there is not an iconographic hanger tag label provide with the oasis drain model.His is a user error, and there is no non-conformance identified with the oasis chest drain.The product in question was not returned and no lot number had been provided.A contemporaneous sample was not required as there was no assertion of a product performance deficiency.No escalation is required as the investigation concludes that the labeling for an oasis chest drain is clear on how to properly fill the water seal chamber.The investigation has concluded that the product in question was not non-conforming.The failure mode is identified in the risk files and the actual occurrence rate does not exceed the anticipated occurrence rate from the risk files.H3 other text: device not available for return.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 18505605
• MDR Text Key: 333332142
• Report Number: 3011175548-2024-00004
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100 - DRAIN DRY SINGLE W/AC
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1