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

Catalog Number K12-MS2666A

Device Problem Product Quality Problem (1506)

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

Event Date 12/13/2013

Event Type  malfunction  

Event Description

The distributor reported that a foreign object was identified in the barrel of the syringe included in the kit during their initial inspection of rec'd product.The device was not sent to a user facility.

Manufacturer Narrative

Device eval: on unused suspect device was returned for eval.A review of the device history record found no exception documents.The complaint database was reviewed and found two similar complaints for this lot number.The device was examined visually, particulate larger than the acceptance criteria was found.The complaint is confirmed for this device.The root cause is attributed to the mfg process.

• 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: 3703682
• MDR Text Key: 4229078
• Report Number: 1721504-2014-00003
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K994253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/13/2013

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: 07/31/2016
• Device Catalogue Number: K12-MS2666A
• Device Lot Number: H517082
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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