MAUDE Adverse Event Report: SVS LLC PREMIERPRO; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	X8435
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Circulator passed scrub tech a pack of lap sponges using sterile technique.When scrub started to count the laps, she noticed a hair between two of them.Tech handed the laps back to circulator and removed her outer gloves.Tech donned new outer gloves.Packaging and laps saved.

• Brand Name: PREMIERPRO
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl; ste 425; charlotte NC 28277
• MDR Report Key: 12016404
• Report Number: 12016404
• Device Sequence Number: 13796836
• Product Code: GDY
• UDI-Device Identifier: 00818566010582
• UDI-Public: (01)00818566010582(17)221126(10)CBI11-05
• 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): 05/28/2021
• Report Date (Section F): 05/28/2021

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: Health Professional
• Device Model Number: X8435
• Device Catalogue Number: X8435
• Device Lot Number: CBI11-05
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94
• Date Report Sent to FDA: 05/28/2021