MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM; DRY SEAL CHEST DRAIN

Model Number 010794

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  Injury  

Event Description

New chest tube kit opened and found to be missing the appropriate tubing to allow chest tube to be connected to new drainage system.

• Brand Name: ATRIUM
• Type of Device: DRY SEAL CHEST DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 7049454
• MDR Text Key: 92770006
• Report Number: MW5073491
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 010794
• Device Catalogue Number: AW010794 RV AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR