MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC; CUSTOM KIT

Catalog Number K12-MS2666A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is part of the (b)(6).(b)(4).One device was visually inspected and a defect in the seal was observed.The complaint was confirmed.The root cause of this failure is attributed to the manufacturing process.One device was returned and evaluated.One device was labeled "for single use." one device was not reprocessed.

Event Description

This report summarizes 1 malfunction event.The distributor reported that a defect in the packaging.This was identified during their initial inspection of received product.The device was not sent to a user facility.No patients were involved.

• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5612123
• MDR Text Key: 44491731
• Report Number: 1721504-2016-00017
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Catalogue Number: K12-MS2666A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1