MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CUSTOM MANIFOLD KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number K09-05755

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 08/02/2016

Event Type  malfunction  

Event Description

Setting up for heart catheterization when it was noticed that three way hook up was cracked on one end.Kit was discarded and a new kit was obtained.

• Brand Name: CUSTOM MANIFOLD KIT
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston avenue; chester VA 23836
• MDR Report Key: 6092400
• MDR Text Key: 59590523
• Report Number: 6092400
• Device Sequence Number: 1
• Product Code: KDD
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: K09-05755
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2016
• 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