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

Catalog Number K12-MS2666A

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2015

Event Type  malfunction  

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 device history record was reviewed and no related exception documents were found.The complaint database was reviewed and no related complaints for this lot number were found.The root cause is attributed to the manufacturing process.A corrective action is in process.

Event Description

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

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 4973305
• MDR Text Key: 23719786
• Report Number: 1721504-2015-00141
• 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: company representative,distri
• Reporter Occupation: Other
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: K12-MS2666A
• Device Lot Number: H778539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• 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