MAUDE Adverse Event Report: Medline Industries, LP Hudson RCI; DBD-O2 CANNULA,ADULT,SOFTECH,7' TUB,SC

Catalog Number	HUD1820
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	Headache (1880)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "the first cannula was tested, and we noticed an unbearable odor, not only from the plastic material of the cannula itself but also a mold-like smell.This caused the patient to develop a headache after using it for a couple of hours.This has never happened before with your cannulas.We then opened two additional cannulas and found the same issue.We tried airing them out by leaving them in open air, but the problem persists.".
Additional Manufacturer Narrative
The report states, "the first cannula was tested, and we noticed an unbearable odor, not only from the plastic material of the cannula itself but also a mold-like smell.This caused the patient to develop a headache after using it for a couple of hours.This has never happened before with your cannulas.We then opened two additional cannulas and found the same issue.We tried airing them out by leaving them in open air, but the problem persists." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Hudson RCI
• Common Device Name: DBD-O2 CANNULA,ADULT,SOFTECH,7' TUB,SC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50430287
• Report Number: 1417592-2026-09134
• Device Sequence Number: 10405075
• Product Code: CAT
• UDI-Device Identifier: 10197344009947
• UDI-Public: 10197344009947
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K210770
• 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): 08/25/2026

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: Health Professional
• Device Catalogue Number: HUD1820
• Device Lot Number: 49125060012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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
• Patient Sex: Unknown