MAUDE Adverse Event Report: SVS LLC PREMIERPRO; DRAPE, SURGICAL

Model Number	8326B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Foreign object in sterile package.

• Brand Name: PREMIERPRO
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate pl; charlotte NC 28277
• MDR Report Key: 19212480
• Report Number: 19212480
• Device Sequence Number: 17868399
• Product Code: KKX
• UDI-Device Identifier: 00818566010193
• UDI-Public: (01)00818566010193(17)280907(10)CBBM09-01
• 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): 02/12/2024
• Report Date (Section F): 02/12/2024

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: 8326B
• Device Catalogue Number: 8326B
• Device Lot Number: CBBM09-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• 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: 02/12/2024