MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. THORACENTESIS/PARACENTESIS TRAY WITH CUSTOM FLUID MANAGEMENT TUBING; GENERAL SURGERY TRAY, CATHETER

Lot Number TRAYT1193159;TUBING:H1197361

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

This is one of several reoccurring kinked tubing incidents.Patient was admitted to the hospital approximately one week ago with the principal problem of heart failure with preserved left ventricular function (hfpef).While an inpatient, approximately two days post admission, the patient underwent a right thoracentesis.It was noted that the tubing on from the fluid management kit within the thoracentesis tray.Did not prevent the procedure from happening.Tray lot #t1193159.Tubing lot #h1197361.The tubing kit is within the para tray, all of these re-occurring events contain tubes from the same lot number.

Manufacturer Narrative

The following elements have blank data.

Event Description

This is one of several reoccurring kinked tubing incidents.Patient was admitted to the hospital approximately one week ago with the principal problem of heart failure with preserved left ventricular function (hfpef).While an inpatient, approximately two days post admission, the patient underwent a right thoracentesis.It was noticed that the tubing was kinked within the thoracentesis tray.This did not prevent the procedure from happening.Tray lot #t1193159.Tubing lot #h1197361.The tubing kit is within the para tray, all of these re-occurring events contain tubes from the same lot number.

• Brand Name: THORACENTESIS/PARACENTESIS TRAY WITH CUSTOM FLUID MANAGEMENT TUBING
• Type of Device: GENERAL SURGERY TRAY, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 w merit pkwy; south jordan UT 84095
• MDR Report Key: 7312685
• MDR Text Key: 101487575
• Report Number: 7312685
• 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,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: TRAYT1193159;TUBING:H1197361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2018
• 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: 90 YR
• Patient Weight: 58