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

Model Number	4000-100N
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.Device not returned.
Event or Problem 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 or Problem Description
N/a.
Additional 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
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8816369
• Report Number: 3011175548-2019-00787
• Device Sequence Number: 11581428
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (Y/N): N
• Initial Reporter State: MD
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 443611
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1