MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; REGULATOR,O2,MINI 0-8 L,870 CGA

Catalog Number	HCS8708M
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a o2 regulator that is not working.It is spewing air from it,".
Additional Manufacturer Narrative
The account reported finding that the o2 regulator was not working, and the facility stated that while setting a pt up in office, "the air started coming out of the two holes in the reg." no sample or photo was received for the investigation; trending was reviewed, the complaint was provided to the component manufacturing facility for further evaluation, and the manufacture/vendor investigation was received.Without the sample to evaluate, medline was unable to confirm the complaint or identify a potential root cause for the reported issue.The division will monitor for 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: REGULATOR,O2,MINI 0-8 L,870 CGA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50472976
• Report Number: 1417592-2026-25419
• Device Sequence Number: 10094083
• Product Code: CAN
• UDI-Device Identifier: 40080196226529
• UDI-Public: 40080196226529
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/26/2026

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: HCS8708M
• Device Lot Number: 41424040001
• Was Device Available for Evaluation?: No
• 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: 01/21/2025
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown