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

Model Number	1806
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upon removing the gauze sponge from its packaging, the nurse noticed the gauze contained black fleck pieces.

• Brand Name: CURITY
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street building 5; mansfield MA 02048
• MDR Report Key: 10270162
• Report Number: 10270162
• Device Sequence Number: 16967572
• Product Code: FRL
• UDI-Device Identifier: 10884521058576
• UDI-Public: (01)10884521058576
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/22/2020
• Report Date (Section F): 06/22/2020

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 Model Number: 1806
• Device Catalogue Number: 1806
• Device Lot Number: 20A111862
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/22/2020