MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CONTROL SYRINGE

Model Number	00884450011874
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint was confirmed through a view of a photograph of the subject device.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during preparations for a percutaneous coronary intervention [pci] procedure, a foreign body was identified within the coronary control syringe [ccs].The ccs was filled saline and inverted to remove all the air from within the syringe when a white foreign body was identified within the barrel.A new ccs was opened and prepped for this procedure.No patient interaction.

• Brand Name: CONTROL SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 9618616
• Report Number: 1721504-2020-00003
• Device Sequence Number: 2739529
• Product Code: DXT
• UDI-Device Identifier: 00884450011874
• UDI-Public: 00884450011874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: 00884450011874
• Device Catalogue Number: CCS600/CNB
• Device Lot Number: H1646933
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1