MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PNEUMOSTAT CHEST DRAIN VALVE; BOTTLE, COLLECTION, VACUUM

Model Number 16100

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.Device not returned.

Event Description

Doctor reported that the bottom connecter on the pneumostat broke off while draining fluid out with a syringe.There were no negative effects to the patient and the pneumostat was replaced with a mini-500.

Manufacturer Narrative

The pneumostat drain was returned and was still full of plural fluid.The syringe port had been broken off.The surrounding area was inspected for signs of other damage.None was noted.The break point of the syringe port was inspected as the syringe port is welded into position during manufacturing.The syringe port was properly welded as indicated by the stress separation marks left behind.The weld area of the syringe port to the drain is tested by the quality inspectors during the process of manufacturing.This requires the test technician to hang a 2lb weight from the syringe port in a parallel position to ensure the integrity of the weld.Additionally every drain is pressure tested to ensure it does not have a leak.As the lot number was not provided a review of the device history records could not be performed.If the lot number had been provided a review of the product quality records and test data would have been conducted.Summary/conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the syringe port was faulty.It is possible that the syringe port was over torqued however this cannot be confirmed.Clinical evaluation - a pneumothorax is a collapsed lung.A pneumothorax occurs when air leaks into the space between the lung and chest wall.This air pushes on the outside of your lung and makes it collapse.Pneumothorax can be a complete lung collapse or a collapse of only a portion of the lung.It can be caused by a blunt or penetrating chest injury, certain medical procedures, or damage from underlying lung disease.Or it may occur for no obvious reason.Symptoms usually include sudden chest pain and shortness of breath.On some occasions, a collapsed lung can be a life-threatening event.Treatment for a pneumothorax usually involves inserting a needle or chest tube between the ribs to remove the excess air.However, a small pneumothorax may heal on its own.It was reported that while aspirating drainage from the drain the bottom connector broke.If excessive force or pressure is applied to the drain it may cause a component to break off resulting in the need to replace the drain.The instructions for use (ifu) states do not use if the device is damaged.The ifu also states the pneumostat chest drain is indicated for the evacuation of air from the chest cavity and is not designed for collection of volumes of fluid.

Event Description

N/a.

• Brand Name: PNEUMOSTAT CHEST DRAIN VALVE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8820466
• MDR Text Key: 152199786
• Report Number: 3011175548-2019-00799
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1