MAUDE Adverse Event Report: COVIDIEN CURITY; GAUZE SPONGE

Model Number	1806
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rn opened a curity 2x2 sterile gauze packet to use on a patient when removing their piv.The gauze contained what looked to be a piece of black duct tape wrapped up inside the gauze.Rn set aside the gauze to report later and opened a fresh gauze for use with the patient.

• Brand Name: CURITY
• Common Device Name: GAUZE SPONGE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9409724
• Report Number: 9409724
• Device Sequence Number: 3999726
• Product Code: NAB
• UDI-Device Identifier: 10884521058576
• UDI-Public: (01)10884521058576
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2019
• Report Date (Section F): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1806
• Device Catalogue Number: 1806
• Device Lot Number: 19H083562
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• 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: 11/11/2019