MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS EXPRESS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number	4000-100N
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that a chest tube that had disconnected from the stop-cock to the pigtail drain.The clinician double clamped the chest tube.The stop-cock and pigtail pulled apart at the connection site.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details of the complaint it was reported that a chest tube had disconnected from the stop-cock to the pigtail drain.The clinician double clamped the chest tube.The stop-cock and pigtail pulled apart at the connection site.It is not very clear on what actually happened during the use of the chest drain but appears as if the pigtail catheter of an unknown origin had been connected to a chest tube that was connected to the express ii single chest drainage system.The drain was not available for return and evaluation, nor was the catheters that were connected to the drain.The additional information that was provided stated that there was a possibility that patient movement most likely contributed to the dislodgement and separation of the pigtail catheter connection from the drain.A review of the device history records shows that this lot of express chest drains passed all quality and performance requirements and that no non-conformances were noted during the process of manufacturing.Additional samples of express chest drains were not pulled from inventory because the reported details stated in all likelihood that the patient movement caused the disconnection of the catheter from the drain and was not related to the functionality of the drain.Based on the details of the complaint and correspondence indicating that the connection was likely due to the patient movement the investigation could not conclude that the drain was defective and therefore cannot confirm the complaint.H3 other text: not available for return.

• Brand Name: DRAINS EXPRESS SINGLE
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11768763
• Report Number: 3011175548-2021-00486
• Device Sequence Number: 3778026
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 01/04/2023
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Device Lot Number: 454001
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1