MAUDE Adverse Event Report: MERMAID MEDICAL A/S M-DRAIN; CATHETER, BILIARY, DIAGNOSTIC

Model Number	D12010035
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) patient, one week postoperative from laparoscopic hysterectomy was admitted the emergency department with increased temperature and abdominal pain.In cat scan, a m-drain multi-purpose percutaneous abdominothoracic drainage catheter was placed in the pelvis.According to the physician, the m-drain catheter had an air leak from a hole in the top third proximal end of tubing or a crack at the hub.The m-drain catheter would not hold suction.Catheter removed and another one inserted without further issues.No known harm to patient and discharged home the same day.

• Brand Name: M-DRAIN
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): MERMAID MEDICAL A/S; 144 research drive; hampton VA 23666
• MDR Report Key: 11692733
• Report Number: 11692733
• Device Sequence Number: 14430681
• Product Code: FGE
• UDI-Device Identifier: 15711055001103
• UDI-Public: (01)15711055001103(17)240101(10)D211A84
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/13/2021
• Report Date (Section F): 04/13/2021

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 Model Number: D12010035
• Device Catalogue Number: D12010035
• Device Lot Number: D211A84
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 167
• Date Report Sent to FDA: 04/13/2021