MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TUBING,OXYGEN,CRUSH RES,25',GREEN,SC-2026-1974-200725710

Catalog Number	HCS4525G
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the cannula is plugged in, the air could not go in or out, and the alarm went off to say that it was not working.
Additional Manufacturer Narrative
It was reported that when the cannula is plugged up, the air could not go in or out, the alarm went off to say that it was not working.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.

• Brand Name: MEDLINE
• Common Device Name: TUBING,OXYGEN,CRUSH RES,25',GREEN,SC-2026-1974-200725710
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes drive; northfield IL 60093 2753
• Manufacturer Contact: muniba anwar ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25369436
• Report Number: 1417592-2026-01974
• Device Sequence Number: 9204710
• Product Code: BYX
• UDI-Device Identifier: 10080196416752
• UDI-Public: 10080196416752
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 06/02/2026

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: Lay User/Patient
• Device Catalogue Number: HCS4525G
• Device Lot Number: 20241020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/03/2026
• 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