MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP HUDSON RCI; O2 MASK,REBREATH,SHORT,ADULT,7' TUB SC

Catalog Number	HUD1009
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the oxygen tubing connection at the mask is loose and can easily disconnect.This occurred during a procedure, under anesthesia.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.
Event or Problem Description
It was reported that the oxygen tubing connection at the mask is loose and can easily disconnect.

• Brand Name: HUDSON RCI
• Common Device Name: O2 MASK,REBREATH,SHORT,ADULT,7' TUB SC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: nakiya graves ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25196059
• Report Number: 1417592-2026-01414
• Device Sequence Number: 10403090
• Product Code: BYG
• UDI-Device Identifier: 10197344011599
• UDI-Public: 10197344011599
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2026

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: HUD1009
• Device Lot Number: 25FOA878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/16/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown