MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TUBING, SUCTION, 1/4" X 10', STRAIGHT

Catalog Number	OR610
Medical Device Problem Codes	Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the connector is more rigid and some if the suction tips will not stay connected.The tubing is also very stiff and keeps a memory.This causes issues on the sterile field.".
Additional Manufacturer Narrative
The account reported finding issues with the connector; the connectors are not staying connected to the yankauers and the tubing is rigid which is causing it to hold memory.A sample was received for investigation, and visual and functional inspection was conducted with the provided samples; finished good production records were reviewed.No abnormalities with connectivity were found, and the connection between the components when assembled meets the strength product specifications, so the connection issue was not confirmed.For the memory issue, the tubing isn't exactly rigid but the way the tubing is packaged causes the tubing to hold its form, and packaging specs are being updated to resolve; the supplier 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: TUBING, SUCTION, 1/4" 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: 50773195
• Report Number: 1417592-2026-40542
• Device Sequence Number: 13191175
• Product Code: GAZ
• UDI-Device Identifier: 40888277319180
• UDI-Public: 40888277319180
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/08/2026

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: OR610
• Device Lot Number: 26024070015
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2024
• 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: 11/19/2024
• 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