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

Catalog Number K09-05755

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Breakage of pressure tubing connector during set up for heart cath.Cath lab tech was tapping the end of a connector to clear air from the line and the connector just snapped off (broke off).Tubing discarded and new set-up obtained.No excessive force.This is the third similar event with this manufacturer's device within the last month.Previous product has been returned to the manufacturer for their review.

• Brand Name: CUSTOM MANIFOLD KIT
• Type of Device: ADAPTOR STOPCOCK MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 4846775
• MDR Text Key: 18389915
• Report Number: 4846775
• 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: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: K09-05755
• Device Lot Number: H757571
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES