MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY CON EPID 19G SPIROL TUOHY

Catalog Number	PAIN9032
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "epidural catheter tubing came disconnected at the connector.".
Additional Manufacturer Narrative
The customer reported that the epidural catheter tubing came disconnected at the connector, the patient declined replacement of the epidural despite unknown timing of disconnect, and prophylactic antibiotics were ordered.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and there were no line down situations, no run without approvals, substitutions, deviations or non-conformance reports, and no issues with the pack build that would contribute to the reported issue.Due to the actual sample used not being available, medline was not able to confirm the quality issue reported, and the cause was unconfirmed with sample required to determine cause.The complaint was provided to the component manufacturing facility for further evaluation, and 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: TRAY CON EPID 19G SPIROL TUOHY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853984
• Report Number: 1417592-2026-47424
• Device Sequence Number: 9923473
• Product Code: OFT
• UDI-Device Identifier: 40195327292035
• UDI-Public: 40195327292035
• 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): 09/21/2026

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: PAIN9032
• Device Lot Number: 24ALA089
• 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: 07/08/2024
• Initial Report FDA Received Date: 09/22/2026
• 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