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

Catalog Number K09-MM2104C

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

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

• Brand Name: MERIT CUSTOM KIT
• 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: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6094837
• MDR Text Key: 59748356
• Report Number: 1721504-2016-00218
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K994253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2016

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: K09-MM2104C
• Device Lot Number: H1009767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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