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

Catalog Number K12-MZTS1201A

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

The distributor reported there is a small hole in the tyvek 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 unused suspect device was returned for evaluation.A review of the device history record found no exception documents.The complaint database was reviewed and found no similar complaints for this lot number.The device was examined visually, there is a small tear in the tyvek material causing the package to not be sealed.The damage appears to have been caused by an external force striking against the packaging material.The complaint is confirmed for this device.Merit is unable to determine the exact root cause of the damage to the packaging material.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: paul kennedy ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084301
• MDR Report Key: 3823864
• MDR Text Key: 4403325
• Report Number: 1721504-2014-00037
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/24/2014

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: 09/30/2016
• Device Catalogue Number: K12-MZTS1201A
• Device Lot Number: H533516
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/21/2014
• 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: Initial
• Patient Sequence Number: 1