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

Catalog Number	PAIN9010S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the sterile barrier for the tray allows betadine to leak through.".
Additional Manufacturer Narrative
This is a combination product the account reported that dr.(b)(6) uses this product and complained that the sterile barrier for the tray allows betadine to leak through.No sample or photo was received for the investigation; production records were reviewed with no line down situations, run without approvals, substitutions, deviations, or non-conformance reports that might have had an impact on this issue, and pack build history was reviewed with no issues that would contribute to the reported issue.Due to the actual sample used not available, medline was not able to confirm what may have caused the csr wrap to allow betadine to leak through; the cause was documented as sample required to determine cause.The supplier quality team will monitor this issue for trending purposes, and there was no report of any patient injury or adverse event.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: EPIDURAL,SINGLE SHOT,20G
• 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: 50840418
• Report Number: 1417592-2026-46142
• Device Sequence Number: 16027689
• Product Code: OGJ
• UDI-Device Identifier: 40884389582801
• UDI-Public: 40884389582801
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 09/18/2026

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: PAIN9010S
• Device Lot Number: 22KLA855
• 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: 02/16/2023
• Initial Report FDA Received Date: 09/21/2026
• 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