MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC THORACENTESIS TRAY; GENERAL SURGERY TRAY

Lot Number TRAY:T1258413TUBING:H1213855

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

This is one of several reoccurring kinked tubing incidents.While setting up for a thoracentesis procedure approximately a week ago at 10 am, the custom fluid management tubing demonstrated a kink.A new thoracentesis tray was opened.The tube from the newly opened tray was used as a substitute.Lot number for thoracentesis tray (t1258413).Lot number for custom fluid management kit (h1213855).This tubing lot number differs from previously submitted reports.

• Brand Name: THORACENTESIS TRAY
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 12701 kingston avenue; chester VA 23836
• MDR Report Key: 7326683
• MDR Text Key: 101977367
• Report Number: 7326683
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2020
• Device Lot Number: TRAY:T1258413TUBING:H1213855
• Other Device ID Number: THORACENTESIS TRAY LOT T12584
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• 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: 47 YR
• Patient Weight: 77