MAUDE Adverse Event Report: Medline Industries LP Medline; SURE SET-SINGLE BASIN

Catalog Number	DYNJS0126
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were 11 raytec in the bundle instead of 10.
Additional Manufacturer Narrative
It was reported that the single basin was opened for parathyroid procedure.During preop counts the staff identified 11 raytec in the bundle instead of the standard 10.All contents of the basin were removed from the sterile field and replaced.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.

• Brand Name: Medline
• Common Device Name: SURE SET-SINGLE BASIN
• Manufacturer (Section D): Medline Industries LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: michael crook ; three lakes dr; northfield, IL 60093
• MDR Report Key: 50881997
• Report Number: 1417592-2026-49641
• Device Sequence Number: 9939287
• Product Code: LRO
• UDI-Device Identifier: 10080196964468
• UDI-Public: 10080196964468
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: DYNJS0126
• Device Lot Number: 26EMA706
• Was Device Available for Evaluation?: Yes
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 185 LB