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

Catalog Number K04-00466C

Device Problems Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909)

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

The actual suspect device was not 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 customer provided a picture of a package showing a hole in the clear film side of the pouch.The remainder of the lot was returned for re-inspection.No additional units were found to have a hole in the packaging.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 as shown in the picture.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CATHETER, INTRAVASCUALR, 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: 3769179
• MDR Text Key: 4438646
• Report Number: 1721504-2014-00011
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: K04-00466C
• Device Lot Number: H548151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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