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 or Device Component (2907)

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

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Cath lab tech setting up for routine heart cath.Manifold set-up in progress and when tapping ao connector to remove air from line the connector broke off.This is the second tubing set that has broken in the same place during same procedure.Tech says that both times she was tapping gently on connector when it broke.No excessive force used on either device.

• Brand Name: CUSTOM MANIFOLD KIT
• Type of Device: ADAPTOR STOPCOCK MANIFOLD
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 4797603
• MDR Text Key: 5854603
• Report Number: 4797603
• Device Sequence Number: 2
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: K09-05755
• Device Lot Number: H757571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 42 YR
• Patient Weight: 136