MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ELECTRODE,NEEDLE,BLUESILK,PTFE-INS,2

Catalog Number	ES0013M
Medical Device Problem Codes	Material Puncture/Hole (1504); Dent in Material (2526)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: DBD-ELECTRODE,NEEDLE,BLUESILK,PTFE-INS,2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50743546
• Report Number: 1417592-2026-37769
• Device Sequence Number: 16044146
• Product Code: GEI
• UDI-Device Identifier: 30080196297225
• UDI-Public: 30080196297225
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Device Catalogue Number: ES0013M
• Device Lot Number: 19HAB531
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 40 LB