MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; LHK, US, SOUTHERN OCEAN COUNTY

Catalog Number	NAM0026
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "the syringe connection is coming undone" allowing air into the system.Due to this, it was reported that "high flow o2, narcan, and neosysnephrine" was required and the "patient returned to baseline".It has been determined that the reported event caused or contributed to serious injury.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
Syringe connection issue.
Additional Manufacturer Narrative
Updated: b4, e1, g1, g3, g6, h2.

• Common Device Name: LHK, US, SOUTHERN OCEAN COUNTY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 22833658
• Report Number: 3015910259-2025-00059
• Device Sequence Number: 17281545
• Product Code: OES
• UDI-Device Identifier: 10195327573669
• UDI-Public: 10195327573669
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: NAM0026
• Device Lot Number: 25ABV069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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