MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; LHK, US, REID HOSPITAL

Catalog Number	VASC1435B
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, while pulling contrast from the contrast bottle, air was observed within the line.
Additional Manufacturer Narrative
According to the facility, while pulling contrast from the contrast bottle, air was observed within the line.The presence of air in the line required staff to be extra cautious due to patient safety concerns, which slowed down the case.There was no report of air entering the patient as a result of the reported issue.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: MEDLINE
• Common Device Name: LHK, US, REID HOSPITAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glens falls; technical park drive; glens falls NY 12801 3864
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24546732
• Report Number: 3015910259-2026-00078
• Device Sequence Number: 17558289
• Product Code: OES
• UDI-Device Identifier: 10198459589164
• UDI-Public: 10198459589164
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 03/09/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1435B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown