MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS DRY SEAL CHEST DRAINS; APPARATUS, AUTOTRANSFUSION

Model Number 4000-100N

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.Device not returned.

Event Description

Hospital reported that they were performing a chest tube procedure on patient and when nurse opened a chest tube drain the tubing was removed from the attached pocket on the back of the drain kit.They noted the protective cap that is normally on the end of the connector was missing.The nurse immediately looked for the cap, but did not see one and placed the chest drain kit out of the room and opened a new kit.

Event Description

N/a.

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.

• Brand Name: EXPRESS DRY SEAL CHEST DRAINS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8816369
• MDR Text Key: 152092972
• Report Number: 3011175548-2019-00787
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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: 03/07/2022
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 443611
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1