MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CENTESIS CATHETER; CATHETER, IRRIGATION

Lot Number I1052740

Device Problem Air Leak (1008)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

The following elements have blank data.

Event Description

This catheter is used for thoracentesis and paracentesis procedures and we are seeing a trend of catheters having an air leak, concerning especially for those cases where the catheter is used in the chest.This air leak appears to be near the hub.Manufacturer response for centesis catheter, centesis catheter (per site reporter).The manufacturer has brushed off our concerns despite the fact that we had three catheter leaks in one day.We do not believe they are taking this issue seriously.

Event Description

This catheter is used for thoracentesis and paracentesis procedures and we are seeing a trend of catheters having an air leak, concerning especially for those cases where the catheter is used in the chest.This air leak appears to be near the hub.Manufacturer response for centesis catheter, centesis catheter (per site reporter): the manufacturer has brushed off our concerns despite the fact that we had three catheter leaks in one day.We do not believe they are taking this issue seriously.

• Brand Name: CENTESIS CATHETER
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston avenue; chester VA 23836
• MDR Report Key: 6375831
• MDR Text Key: 68989691
• Report Number: 6375831
• Device Sequence Number: 1
• Product Code: GBX
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: I1052740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR