MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT

Catalog Number K08-MS3069

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The distributor reported that a foreign object was found in the fluid path of the tubing in the kit.This was identified during their initial inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

One device returned for eval.The eval is in process.A f/u report will be sent when the eval has been completed.

• Brand Name: MERIT CUSTOM KIT
• 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: 4360635
• MDR Text Key: 18919500
• Report Number: 1721504-2014-00292
• 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: 12/08/2014

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: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: K08-MS3069
• Device Lot Number: H704606
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1