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

Model Number K1206178

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

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

Manufacturer Narrative

One device has been returned for evaluation.The complaint is 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.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 7038533
• MDR Text Key: 93298548
• Report Number: 9616662-2017-00030
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884913
• 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,Followup
• Report Date: 10/31/2017

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: K1206178
• Device Catalogue Number: K05-YSI042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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