MAUDE Adverse Event Report: CARDINAL HEALTH, INC. CURITY; FIBER, MEDICAL, ABSORBENT

Model Number	6939
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Foreign material inside sterile package.

• Brand Name: CURITY
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19509869
• Report Number: 19509869
• Device Sequence Number: 3394310
• Product Code: FRL
• UDI-Device Identifier: 10884521059320
• UDI-Public: (01)10884521059320
• 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): 03/04/2024
• Report Date (Section F): 03/04/2024

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
• Device Model Number: 6939
• Device Catalogue Number: 6939
• Device Lot Number: E23091329S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2024
• 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: 03/04/2024