MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LHK,US,MTS,RWATSON,CLINIC-LAKE

Catalog Number	VASC1678
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotating adaptor broke during use and handles dislodged and can turn full 360 degrees.
Additional Manufacturer Narrative
The account reported finding broken manifold and reported the rotating adaptor broke during use and the handles dislodged, turning the full 360 degrees.A box containing 21 sealed, unopened pouches was received for review; the reported defective sample was not received and had been discarded by the customer, and 20 samples were opened, visually inspected, leak tested, and had the swage on the rotating adaptor inspected with passing results and no defects found.In the absence of a defect sample or a visual representation such as a photo for inspection and testing, medline is currently unable to verify the customer's claim regarding a broken manifold.No root cause was identified, and if a photo or sample of the reported defect becomes available, this complaint will be re-opened and investigated.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: LHK,US,MTS,RWATSON,CLINIC-LAKE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947887
• Report Number: 1417592-2026-54510
• Device Sequence Number: 10429611
• Product Code: OES
• UDI-Device Identifier: 10198459241468
• UDI-Public: 10198459241468
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2026

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: VASC1678
• Device Lot Number: 25BBJ631
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2025
• 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: 05/14/2025
• Initial Report FDA Received Date: 09/30/2026
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 97 LB
• Patient Race: White