MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LHK, US, NORTHBAY MED CENTER

Catalog Number	VASC1489A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the manifold end snapped off" and "we just had another one break this weekend at the same location.".
Additional Manufacturer Narrative
The customer reported two manifolds break and stated the manifold end snapped off mid case; the customer also reported that no patients were harmed with the malfunction.A photo was received for evaluation, and the photo received from the customer confirms the complaint of the rotating adaptor (ra) to be separated from the manifold; no sample was available to evaluate.Based on review of the manifold dhr and drawing, the item meets specifications, and without the sample for evaluation and review, the root cause could not be confirmed at this time.No further action is required at this time as there is no sample yet available to evaluate, and medline will continue to monitor for additional occurrences and adverse trends.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, NORTHBAY MED CENTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899317
• Report Number: 1417592-2026-51143
• Device Sequence Number: 18817968
• Product Code: OES
• UDI-Device Identifier: 10198459155024
• UDI-Public: 10198459155024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: VASC1489A
• Device Lot Number: 24JBX902
• 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: 02/24/2025
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown