MAUDE Adverse Event Report: MERIT MEDICAL INC CUSTOM MANIFOLD KIT REVISION F; ADAPTOR STOPCOCK MANIFOLD

Catalog Number K09-05755

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

During set up for heart cath, discovered custom manifold kit did not have a hook-up for contrast.Only has two ports where it normally has three.This facility has had mulitple problems with this manufacturer's product over the last month.The manufacturer has been notified and product has been returned.

• Brand Name: CUSTOM MANIFOLD KIT REVISION F
• Type of Device: ADAPTOR STOPCOCK MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL INC; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 4877547
• MDR Text Key: 16561018
• Report Number: 4877547
• Device Sequence Number: 1
• Product Code: DTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: K09-05755
• Device Lot Number: H745404
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 58 YR
• Patient Weight: 115