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

Model Number 3600-100

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported the provider experienced ports on two of the #3600-100 fail on them, to the left of the blue suction valve.They went to flush and the port became stuck.

Manufacturer Narrative

This complaint claims that the user attempted to "flush" the drain through the port "left of the blue suction valve." two possible meanings are being considered for this, depending on how the user may have the drain oriented when describing the location of the "port." the user did not return the drain or provide pictures.Multiple attempts were made to acquire additional information from the complainant, but no response was received.They may mean they are attempting to empty the drain through the pprv, which is not the intended purpose of the pprv.The pprv (positive pressure release valve) is intended to allow fluid to exit the drain when the drain fills or has positive pressure.This allows the drain to continue to function until it can be replaced.The ifu instructs the user to replace the drain if it becomes full, so the user should not be attempting to empty it.If they pour fluid through the pprv, it is possible for it to congeal in the vent, clogging it and preventing any more fluid from being able to pass through.They may also mean that they depressed the mvv to attempt to relieve the negative pressure in the drain and lower the height of the water seal column and the spring mechanism became stuck.Because it is not clear which scenario the user is describing and they did not provide any further information when asked, a definite root-cause cannot be determined.The root-cause of this complaint is impossible to define.A dhr review was completed which found no anomalies in the manufacturing process.No ncrs involving this lot were identified.The incoming inspection record for the drain subassembly used in this device was reviewed and no anomalies were identified.Relevant manufacturing procedures and device/part specifications were reviewed and no changes or inadequacies were identified which would likely contribute to this complaint.No evidence was found to suggest manufacturing was the cause of this complaint.The ifu provides adequate instructions for the setup and use of the device and contains all the information required to avoid this failure.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity cannot be confirmed with the provided information or with the information reviewed in this investigation.A definite root-cause cannot be determined because it is not clear exactly what failure occurred.The root-cause for this complaint is impossible to define.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.H3 other text : device not returned.

• 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: 15447818
• MDR Text Key: 305972798
• Report Number: 3011175548-2022-00258
• 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: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 477971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1