MAUDE Adverse Event Report: Medline Industries, LP CENTURION; NEEDLE HOLDER,MAYO HEGAR,OR 6(OR2500) ST

Catalog Number	67870
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction

• Brand Name: CENTURION
• Common Device Name: NEEDLE HOLDER,MAYO HEGAR,OR 6(OR2500) ST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; three lakes drive, IL 60093--275
• MDR Report Key: 50614752
• Report Number: 1417592-2026-32536
• Device Sequence Number: 10742615
• Product Code: GEN
• UDI-Device Identifier: 00653160196894
• UDI-Public: 00653160196894
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 67870
• Device Lot Number: 2023091290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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 Sex: Unknown