MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SYRINGE.CCS.INJECT8¿.8 ML.ROTATING MALE LUER ADAPTER.RING; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Catalog Number	CCS880/C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined.The device history record was reviewed and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that the a foreign object was identified within the fluid path of the medical device.This was identified during an actual procedure.Embolic risk to the patient identified.The device was exchanged for a new one.No patient injury to report.

• Brand Name: SYRINGE.CCS.INJECT8¿.8 ML.ROTATING MALE LUER ADAPTER.RING
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19760328
• Report Number: 1721504-2024-00041
• Device Sequence Number: 18428178
• Product Code: DXT
• UDI-Device Identifier: 00884450606506
• UDI-Public: 884450606506
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Catalogue Number: CCS880/C
• Device Lot Number: H2908057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2002
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown