MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRA® JARIT®; HEMOSTAT

Model Number	105161
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument staining, discoloration of unknown origin after repeated cleaning & sterilization.

• Brand Name: INTEGRA® JARIT®
• Common Device Name: HEMOSTAT
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd; mansfield MA 02048
• MDR Report Key: 18535043
• Report Number: 18535043
• Device Sequence Number: 6732149
• Product Code: HRQ
• UDI-Device Identifier: 10381780375685
• UDI-Public: (01)10381780375685(10)AD2202
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2023
• Report Date (Section F): 09/25/2023

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 Model Number: 105161
• Device Catalogue Number: 105-161
• Device Lot Number: AD2202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/25/2023