MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; YANKAUER,OPEN TIP,VENTED,STERILE

Catalog Number	OR87V
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our surgery manager identified a yankauer straight tip that was defective.The tip seems to be missing the round edge resulting in jagged edge which is dangerous for the patient".
Additional Manufacturer Narrative
The account reported finding missing the round edge, and the complaint stated that the tip seems to be missing the round edge resulting in jagged edge which is dangerous for the patient.A photo was received for our investigation, visual inspection was conducted with the provided pictures, and finished good production records were reviewed.Based on the complaint details, picture evaluation and our investigation, the complaint was confirmed.The vendor identified that during the production process, an abnormal alarm was triggered by the equipment and a machine adjustment action was initiated; after the machine adjustment, the products were not specifically distinguished and monitored, resulting in not being selected in full product inspection, and the division will continue to monitor the issue for trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: YANKAUER,OPEN TIP,VENTED,STERILE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931390
• Report Number: 1417592-2026-52878
• Device Sequence Number: 13138820
• Product Code: JOL
• UDI-Device Identifier: 10888277407954
• UDI-Public: 10888277407954
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• 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: OR87V
• Device Lot Number: 18324100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/25/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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