MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NDL TUOHY 20G X 3.5 FIXED WING

Catalog Number	PAIN8045
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "needle bent upon contact with the patient spine, there is also visible bowing.".
Additional Manufacturer Narrative
The customer reported the needle bent upon contact with the patient spine with visible bowing; the device was being used "as per usual for an interlaminar epidural," the procedure was completed, and "no patient is fine." no sample or photo was received for the investigation; without a lot number, a dhr review and pack review could not be performed, and account and product trending found 0 additional reported complaints for this issue in the past 24 months.Due to not receiving the actual sample used, medline was not able to confirm what may have caused the issue, and the cause code states "sample required to determine cause." 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: NDL TUOHY 20G X 3.5 FIXED WING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898429
• Report Number: 1417592-2026-50993
• Device Sequence Number: 16130311
• Product Code: BSP
• UDI-Device Identifier: 10193489902822
• UDI-Public: 10193489902822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K854816
• 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): 09/24/2026

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: PAIN8045
• 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: 09/17/2025
• Initial Report FDA Received Date: 09/25/2026
• 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