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

Catalog Number K12T-08316A

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 02/25/2015

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The device was visually inspected and a breach in the sterile barrier was identified.The complaint is confirmed.The scissors in the kit have a sharp point and caused a hole in the packaging.A protective wrap has been added to the kit to prevent this from reoccurring.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 user reported a defect in the packaging.This damage was discovered when the kit was taken out of the shipping box.The kit was not used on a patient.

• Brand Name: STERILIZED CONVENIENCE KIT
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 12701 kingston ave; chester VA 23836
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 5033708
• MDR Text Key: 24207024
• Report Number: 1125782-2015-00033
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: K12T-08316A
• Device Lot Number: T752346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2015
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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