MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBING, SUCTION, 3/16" X 10', STRAIGHT

Catalog Number	OR510T
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tubing is not staying connected to the machine.".
Additional Manufacturer Narrative
The account reported finding tubing not staying connected.One (1) ea was received in its original packaging for investigation; a visual and physical inspection was conducted on the provided sample, finished good production records were reviewed, and component trending was reviewed.The reported problem was not confirmed: no visible issues were identified, both sides were connected and remained securely connected with no signs of loosening or improper fit observed, and the male adaptor was able to connect to suction tubing connectors as intended.Based on customer feedback, the customer used the male adaptor to connect the tubing to the drain bag; the male adaptor is intended to connect suction tubing together and is not intended for connections between other types of equipment, and the complaint was determined to be customer misuse and not a product quality issue.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: TUBING, SUCTION, 3/16" X 10', STRAIGHT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773178
• Report Number: 1417592-2026-40538
• Device Sequence Number: 9717130
• Product Code: GAZ
• UDI-Device Identifier: 10888277319134
• UDI-Public: 10888277319134
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/09/2026

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: OR510T
• Device Lot Number: 48625100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• 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: 03/09/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown