MAUDE Adverse Event Report: ATRIUM MEDICAL EXPRESS PREFILLED DRAINS; APPARATUS, AUTOTRANSFUSION

Device Problem Air Leak (1008)

Patient Problems Dyspnea (1816); Pain (1994); Pneumonia (2011); Pneumothorax (2012); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study the patients with air leaks can be safely discharged home with their chest tubes.

Event Description

Received an article titled "the removal of chest tubes despite an air leak or a pneumothorax".The purpose of the article was to evaluated the safety of chest tube removal in patients with an air leak.Per the article adverse events included empyema, air leak, pneumothorax, gastrointestinal complaints, pain, pneumonia, transient ischemic attack and progressive dyspnea.

• Brand Name: EXPRESS PREFILLED DRAINS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7535861
• MDR Text Key: 108976906
• Report Number: 3011175548-2018-00505
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K081718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention