MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number K12-MZT8201A

Device Problems Contamination (1120); Hole In Material (1293)

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

Event Date 02/18/2014

Event Type  malfunction  

Event Description

The distributor reported there is a small hole in the clear film material of the package causing a breach in the sterile barrier.This was identified during their initial inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

Device evaluation.One new device was returned for evaluation.The device history record was reviewed and found no exception documents.The complaint database was reviewed and found no similar complaints for this lot number.The returned device was examined and the complaint is confirmed.A hole was found in the clear packaging.The hole was caused by a component handle being forced into the packaging material.The hole appears to have been caused by rough, or improper handling.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3829916
• MDR Text Key: 4403930
• Report Number: 1721504-2014-00055
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: K12-MZT8201A
• Device Lot Number: H535484
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1