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

Catalog Number K12-MS2666A

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

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

Event Date 11/13/2014

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 received product.The device was not sent to a user facility.

Manufacturer Narrative

Device evaluation: one unused suspect device was returned for evaluation.The device was examined visually.Particulate larger than the acceptance criteria was found.The complaint was confirmed for this device.The root cause is attributed to the manufacturing process.A corrective action is in process.The device history record was reviewed and no related exception documents were found.The complaint database was reviewed and related complaints for this lot number were found.

• 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: 4344549
• MDR Text Key: 16561274
• Report Number: 1721504-2014-00282
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K994253
• 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: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: K12-MS2666A
• Device Lot Number: H673056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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