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

Model Number	2187
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
When opening a packet of sterile curity¿4x4 gauze sponges, there was something brown identified in the gauze.A second package of gauze was opened with a cluster of 3 brown particles.Gauze was not used on patient.

• 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: 12655919
• Report Number: 12655919
• Device Sequence Number: 1309355
• Product Code: FRL
• UDI-Device Identifier: 10884521058705
• UDI-Public: (01)10884521058705
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/06/2021
• Report Date (Section F): 10/06/2021

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: No Information
• Device Model Number: 2187
• Device Catalogue Number: 2187
• Device Lot Number: D20122530S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/06/2021