MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND HONOR HEMOSTASIS VALVE

Model Number	00884450013137
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.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.
Event or Problem Description
The account alleges that there was white plastic deposit within the valve.

• Brand Name: HONOR HEMOSTASIS VALVE
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 10680961
• Report Number: 9616662-2020-00013
• Device Sequence Number: 2960791
• Product Code: DTL
• UDI-Device Identifier: 00884450013137
• UDI-Public: 00884450013137
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 02/16/2023
• Device Model Number: 00884450013137
• Device Catalogue Number: MAP300
• Device Lot Number: K1786469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1