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

Catalog Number	RTACIBOM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the needle on the gauge has come off.".
Additional Manufacturer Narrative
The account reported finding "needle on the gauge has come off." medline received two of the item for investigation and visually inspected the samples; the vendor was notified of the customer's concern, and this medline labeled product was sent to vendor for investigation.The reported issue was confirmed with the samples received.The cause was documented as "cannot determine cause w/received sample," and reportability has not changed; the quality team will monitor this issue for trending purposes.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: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50267795
• Report Number: 1417592-2026-17780
• Device Sequence Number: 16038831
• Product Code: KDP
• UDI-Device Identifier: 10193489014310
• UDI-Public: 10193489014310
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/14/2026

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: 10/14/2024
• 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: 10/04/2024
• Initial Report FDA Received Date: 08/16/2026
• 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