MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS MINI 500; BOTTLE, COLLECTION, VACUUM

Model Number 16400

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Report received from daughter stated her mom had lung removed and is home with a drainage system.When attaching the 60ml syringe to drain the fluid it is not coming out.It looked like there was tissue blocking the plunger in the device.Air was put in to try and move the tissue but it still was not letting fluid out with syringe.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint, it was reported that a patient had a lung removed and was sent home with a 16400-drain express mini 500.The patient was advised to empty the drain daily via the sample port with a luer lock syringe.When attaching the 60ml syringe to drain the fluid did not come out.The person reporting the complaint indicated that it looked like there was tissue blocking the plunger in the device.Air was put into the device to try to move the tissue but it still did not let fluid out with the syringe.After several days, the plastic piece of the sample port was pushed in and the device began leaking.Fluids could not be removed, resulting in a full chest drain.The patient contacted the thoracic surgeon¿s office and was told to come in and the chest tube was removed.Based on the details provided, the drain express mini 500 was provided for home use for the patient.In addition, the patient was instructed to empty the drain daily via the sample port.When the sample port became clogged, attempts were made to dislodge the blockage with air.The situation and attempts at problem solving are in opposition to the instructions for use, which indicates the following precautions: replace chest drain if damaged or when collection volume meets or exceeds maximum capacity, if needleless luer port becomes clogged replace with a new device and users should be familiar with thoracic surgical procedures and techniques before using a chest drain.As no lot number was provided, device history records could not be reviewed for the device.A 2-year review of the receiving inspection records for the supplier of the nac valve part number was conducted and there were no non-conformances related to the complaint description.The investigation could not conclude that the drain was defective and therefore cannot confirm the complaint.H3 other text: device not available for return.

Event Description

N/a.

• Brand Name: EXPRESS MINI 500
• 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: 11356624
• MDR Text Key: 232790826
• Report Number: 3011175548-2021-00199
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female