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

Catalog Number K12-MZT8201A

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

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

The distributor reported that a hole in the sterile package was identified during their initial inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

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.The outer packaging was punctured by a component from within the package.The packaging film at the hole site is stretched as if from an impact to the package causing the breach in the sterile barrier.The complaint is confirmed for this device.The root cause is attributed to rough or improper handling.Merit is unable to determine the exact root cause for the damage to the outer packaging.

• 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 parkway; south jordan, UT 84095 ; 8012084301
• MDR Report Key: 3769180
• MDR Text Key: 4437015
• Report Number: 1721504-2014-00010
• 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: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2013

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: 06/30/2016
• Device Catalogue Number: K12-MZT8201A
• Device Lot Number: H505366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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