MAUDE Adverse Event Report: Merit Medical Systems Inc. Syringe Medallion®; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Catalog Number	MSS121-LB/B
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges a foreign material in the syringe packaging during their incoming inspection.The items were not released to the hospital.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Visual inspection identified contamination similar to fiber and black contamination.Two units had contamination inside the syringe fluid path, and eight units had contamination in the non-fluid path area.The complaint was confirmed.The root cause was determined to be environment.A search of the complaint database was performed and no similar complaints for this lot number were found.The product history record was reviewed, and no exception documents were found.

• Brand Name: Syringe Medallion®
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50947120
• Report Number: 1721504-2026-00478
• Device Sequence Number: 10429589
• Product Code: FMF
• UDI-Device Identifier: 00884450610084
• UDI-Public: 00884450610084
• Combination Product (Y/N): N
• Initial Reporter Country: PRK
• PMA/510(K) Number: K173601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Catalogue Number: MSS121-LB/B
• Device Lot Number: H3471300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown