MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTO,NAMIC,CUSTOM,KIT,C0798,BAK-3085,-,PG

Catalog Number	000000000065690079
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: MTO,NAMIC,CUSTOM,KIT,C0798,BAK-3085,-,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50938883
• Report Number: 1417592-2026-53929
• Device Sequence Number: 9598162
• Product Code: OEZ
• UDI-Device Identifier: 10193489064247
• UDI-Public: 10193489064247
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/28/2026

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: 000000000065690079
• Device Lot Number: 0000104763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2024
• 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: 03/14/2024
• Initial Report FDA Received Date: 09/29/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown