MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; REGULATOR,SUCTION,C/I,NPT TRAP BTM,CHEM

Catalog Number	RTACIVCM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "regualtors being jammed.".
Additional Manufacturer Narrative
The account reported that the regulator is jammed.No sample or photo received for our investigation; review of the previous 3 sop-00032 trend reports has been completed for trending purposes, and no trends identified.According to the vendor, based on review of the information provided by the customer, customer stated of regulators being jammed is interpreted as the regulating adjustment knob is not moving, and this can be due to overtightening to the closed position, making it difficult to open back up.Customer was sent instructions on how to fix the issue, and they were able to solve the reported issue; reportability has not changed.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,C/I,NPT TRAP BTM,CHEM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50552412
• Report Number: 1417592-2026-30208
• Device Sequence Number: 18788719
• Product Code: KDP
• UDI-Device Identifier: 10193489080544
• UDI-Public: 10193489080544
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/01/2026

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: RTACIVCM
• 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: 01/28/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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