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

Catalog Number K04-MZ6150A

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The device was examined visually and the complaint was confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exceptions documents were found.

Event Description

The distributor alleged a defect in the packaging.This was identified during their initial inspection of received product.The device was not sent to a user facility.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan UT 94095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 94095
• MDR Report Key: 7041685
• MDR Text Key: 93082874
• Report Number: 1721504-2017-00233
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: K04-MZ6150A
• Device Lot Number: H1186924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1