MAUDE Adverse Event Report: ATRIUM MEDICAL OCEAN DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 2002-300

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that a small hole was noticed in the packaging of the drain.

Manufacturer Narrative

The unit was received and inspected.There was a small hole found in the tyvek portion of the chest drain pouch.The hole was located on the backside of the drain and was approximately 3mm long and 2mm wide.There were no other signs of damage to the chest drain or the blue csr wrap.A review of the device history records was performed, including the performance testing results of the product.This review has determined that there were no anomalies during the manufacture of the product.The product met all quality requirements.Review of the handling and distribution test that was conducted on the drain product found that there were no breaches of the sterile barrier during the testing.Based on the results of the investigation it is likely that the packaging of the chest drain was compromised after leaving the atrium medical manufacturing facility, possibly either during shipping or handling process.The ocean chest drainage system is indication for use the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.A package that is damaged would be noticed prior to admission to a sterile field.Damaged packaging may be the result of improper storage conditions or shipping occurrences.The instructions for use (ifu) instructs to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and to not use if device or package is damaged.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.

• Brand Name: OCEAN DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7862738
• MDR Text Key: 119938812
• Report Number: 3011175548-2018-00999
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862100105
• UDI-Public: 00650862100105
• Combination Product (y/n): N
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Model Number: 2002-300
• Device Catalogue Number: 2002-300
• Device Lot Number: 428202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/27/2018
• Supplement Dates FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1