MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CONTINUOUS EPIDURAL TRAY

Catalog Number	PAIN1816A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿catheter connector threaded far from catheter indicator tip¿ and ¿risk for contamination¿; the customer stated, ¿the catheter has been placed in the sleeve backward- basically the tip that is inserted is coiled last instead of first.¿.
Additional Manufacturer Narrative
The customer reported that the catheter connector was threaded far from the catheter indicator tip and that the catheter had been placed in the sleeve backward, basically the tip that is inserted is coiled last instead of first.A photo was received, the customer provided a video of the component, finished good production records were reviewed, the finished good pack build was reviewed, and trending was reviewed.Based on the complaint details, video evaluation, and investigation, the complaint was confirmed; the video confirmed that the thread assistant guide for the catheter was located at the end of the catheter.The root cause was determined to be customer preference, and the investigation concluded that the actual location of the thread assistant guide when the component is received does not impact the ability to use the component correctly, as the guide can be moved to the correct spot since it is free-moving.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: CONTINUOUS EPIDURAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913631
• Report Number: 1417592-2026-51820
• Device Sequence Number: 5330382
• Product Code: OFT
• UDI-Device Identifier: 10195327322243
• UDI-Public: 10195327322243
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/25/2026

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: PAIN1816A
• Device Lot Number: 25FBT701
• Was Device Available for Evaluation?: Yes
• 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: 10/24/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (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