MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; DULUTH SURGICAL SUITES DA HIP

Catalog Number	DYNJ86347A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The suction tip (yankauer) is twisted/not usable.The staff has replaced them with individuals off the shelf.
Additional Manufacturer Narrative
It was reported that the suction tip (yankauer) is twisted/not usable.The staff has replaced them with individuals off the shelf.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: DULUTH SURGICAL SUITES DA HIP
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo, 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25225488
• Report Number: 1423395-2026-00171
• Device Sequence Number: 13211935
• Product Code: LRO
• UDI-Device Identifier: 10198459174612
• UDI-Public: 10198459174612
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: DYNJ86347A
• Device Lot Number: 25HBS644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown