MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Based on the results of the investigation the removal of the tube set caps was part of a company initiative to enhance the clinician experience, reduce our carbon footprint and reduce waste.[(b)(4)].Device not returned.

Event Description

Medwatch received from fda that the user facility (uf # (b)(4)) reported the drain connector tubing caps missing from the tubing assembly.Hospital had issues with it coming loose with normal handling and causing the exposed tubing tip to touch the floor or wall thus causing us to reopen another package.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8686910
• MDR Text Key: 147862708
• Report Number: 3011175548-2019-00650
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K053140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 444010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1