MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; REGULATOR,SUCTION,CONT/INT,BARB B,OHMEDA

Catalog Number	RTACIBOM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the unit is not functioning and the knob does not work.".
Additional Manufacturer Narrative
The account reported finding ¿the unit is not functioning and the knob does not work.¿ a sample was received for investigation and sent to the vendor; visual inspection revealed the unit to be in good condition, vacuum suction was present after vacuum testing, the knob was found to be overtightened and stiff when rotated, extra force was applied and the knob was able to engage with the unit, and the unit was further disassembled and found in good condition.The cause code was unconfirmed defect - not confirmed with received sample.No root cause was identified in the record, and the vendor stated that no further investigation is required.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,SUCTION,CONT/INT,BARB B,OHMEDA
• 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: 50483998
• Report Number: 1417592-2026-26532
• Device Sequence Number: 10093454
• Product Code: KDP
• UDI-Device Identifier: 10193489014310
• UDI-Public: 10193489014310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/27/2026

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: RTACIBOM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/04/2023
• 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: 09/19/2023
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown