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

Model Number	D40105007
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with a history of hypertension, recent shortness of breath, and right pleural effusion was admitted for a right thoracentesis.When the mermaid medical a/s m-drain centesis catheter was opened, it was observed that the catheter that was identified as a 5f x 7cm centesis catheter had a needle that was 12 cm long instead.This device was not used on the patient.Please note this is the 3rd report for the same product.

• Brand Name: M-DRAIN CENTESIS CATHETER
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): MERMAID MEDICAL A/S; 144 research drive; hampton VA 23666
• MDR Report Key: 12127301
• Report Number: 12127301
• Device Sequence Number: 3490466
• Product Code: GCB
• UDI-Device Identifier: 15711055001981
• UDI-Public: (01)15711055001981(17)260121(10)P001510
• 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): 06/22/2021
• Report Date (Section F): 06/22/2021

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: D40105007
• Device Catalogue Number: D40105007
• Device Lot Number: P001510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 46
• Date Report Sent to FDA: 06/22/2021