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

Catalog Number K09-MST2176A

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

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

Event Date 04/03/2014

Event Type  malfunction  

Event Description

The distributor reported there is a small hole in the tyvek 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 suer facility.

Manufacturer Narrative

Device evaluation: one new device was returned for evaluation.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.The returned device was examined and the complaint is confirmed.A hole was found in the tyvex.The tyvek appears to be thin and the extra stress on the package resulted in a tear that was not part of the seal.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: 3944074
• MDR Text Key: 4535888
• Report Number: 1721504-2014-00089
• 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: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/03/2014

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: 02/28/2017
• Device Catalogue Number: K09-MST2176A
• Device Lot Number: H592977
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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