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

Catalog Number K12-MS2666A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception 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 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan 84095
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 6764169
• MDR Text Key: 81739157
• Report Number: 1721504-2017-00156
• 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: 07/04/2017

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: No Information
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: K12-MS2666A
• Device Lot Number: H1116218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1