MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 20G SINGLE SHOT EPIDURAL TRAY

Catalog Number	PAIN2002B
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the 20g needle is very flimsy and the stylet is plastic.The needle bends as it's being inserted into the patient.".
Additional Manufacturer Narrative
The account reported finding "flimsy needle bending," and physicians expressed dissatisfaction with how flimsy the needles are and used an alternative needle.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and there were no issues identified that would contribute to the reported issue.Due to not receiving the actual sample used, medline was not able to confirm what may have caused the issue.The quality team will monitor this issue for trending purposes, and no medical intervention, serious injury, or follow-up care has been reported.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: 20G SINGLE SHOT EPIDURAL TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820365
• Report Number: 1417592-2026-44897
• Device Sequence Number: 10211062
• Product Code: OFT
• UDI-Device Identifier: 10198459281051
• UDI-Public: 10198459281051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2026

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: PAIN2002B
• Device Lot Number: 25GBL549
• 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: 08/25/2025
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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