MAUDE Adverse Event Report: CARDINAL HEALTH, INC. VISTEC; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7317
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a simulation of an operating room event, the nurse was showing how to empty a package of vistec xray detectable sponges (10 count) on the sterile field using sterile technique.After opening the pack, when she dumped, one sponge remained partially adhered to pack.When we counted the sponges that remained in the paper wrap, only 9 were wrapped.

• Brand Name: VISTEC
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15292832
• Report Number: 15292832
• Device Sequence Number: 15245439
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: (01)10884527016990
• 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): 08/11/2022
• Report Date (Section F): 08/11/2022

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: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 20D124062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 08/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2022
• 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: 08/11/2022