MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; REGULATOR,MINI,0-15LPM,870 CGA

Catalog Number	HCS8715MA
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: REGULATOR,MINI,0-15LPM,870 CGA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50936431
• Report Number: 1417592-2026-53591
• Device Sequence Number: 9563809
• Product Code: CAN
• UDI-Device Identifier: 10080196193905
• UDI-Public: 10080196193905
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: HCS8715MA
• 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: 06/04/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown