MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PARACENTESIS TRAY WITH CUSTOM FLUID MANAGEMENT KIT; GENERAL SURGERY TRAY

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

This is one of several reoccurring kinked tubing incidents.This report was the first of the series discovered between the beginning of this year and to the present.Early this year, the patient presented for a paracentesis procedure.The fluid management tubing that was used for the patient's procedures was badly kinked.It slowed down the drainage of the fluid during the procedure but did not cause harm to the patient.Unfortunately, the team did not know this would be the first in a series of events and did not save the packaging.

• Brand Name: PARACENTESIS TRAY WITH CUSTOM FLUID MANAGEMENT KIT
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 7348423
• MDR Text Key: 102738905
• Report Number: 7348423
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 101