MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ACCU-SORB GAUZE SPONGE; GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE

Model Number	NON21430LF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of severe spinal stenosis.Procedure: lumbar instrumentation fusion 4+ levels, intersegmental decompression lumbar 2-lumbar 3, lumbar 3-lumbar 4, lumbar 4-lumbar 5, lumbar 5-sacral 1.When setting up for surgery, the medline x-ray detectable gauze sponges were removed from packaging and had foreign substance attached.Not used or put onto surgical field.No known harm to patient.Manufacturer response for gauze / sponge, nonresorbable for external use, medline (per site reporter).Unknown.

• Brand Name: ACCU-SORB GAUZE SPONGE
• Common Device Name: GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 17975038
• Report Number: 17975038
• Device Sequence Number: 14066980
• Product Code: NAB
• UDI-Device Identifier: 10080196832347
• UDI-Public: (01)10080196832347(17)26022120023(10)NON21430LF
• 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): 10/06/2023
• Report Date (Section F): 10/06/2023

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: NON21430LF
• Device Catalogue Number: NON21430LF
• Device Lot Number: 26022120023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 10/06/2023