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

Catalog Number TRAYK12T-04435DTUBINGK08-2588

Device Problem Kinked (1339)

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

Event Date 03/06/2018

Event Type  malfunction  

Event Description

This is one of several reoccurring kinked tubing incidents.While admitted to the hospital, the patient was to have us guided paracentesis.Kinked custom management fluid tubing was noted to be kinked at the time of the procedure.The tubing was used and did not affect the procedure nor did it cause harm to the patient.The lot number for the para tray is t1226758.The custom fluid management kit lot number is h1197361.The tubing lot number matches 4 of the previously reported incidents.

• 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: 7372974
• MDR Text Key: 103583594
• Report Number: 7372974
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: TRAYK12T-04435DTUBINGK08-2588
• Device Lot Number: TRAY:T1226758;TUBING:H1197361
• Other Device ID Number: PARA TRAY LOT #T1226758 CATAL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• 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: 75 YR
• Patient Weight: 106