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

Catalog Number	PAIN0029A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported: "hole in the betadine, could not use.".
Additional Manufacturer Narrative
The account reported, ¿hole in the betadine, could not use,¿ and the complaint transcript states it was ¿confirmed not used on a patient, discovered before use.¿ no sample or photo was received for the investigation; production records, pack build history, account complaint history, and component complaint history were reviewed, with no line down situations, approvals/substitutions/deviations/non-conformance reports, pack build issues, or similar reported issues in the past 6 months identified.The reported complaint could not be confirmed, and the cause code states ¿sample required to determine cause.¿ the investigation concluded that based on the component¿s location in the pack it is unlikely that placement contributed to the reported issue, and the division will monitor for trends.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: DBD-SINGLE SHOT EPIDURAL TRAY 20G
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50917548
• Report Number: 1417592-2026-52329
• Device Sequence Number: 17478956
• Product Code: OFT
• UDI-Device Identifier: 40884389474380
• UDI-Public: 40884389474380
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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

• Device Catalogue Number: PAIN0029A
• Device Lot Number: 22KLA954
• 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: 05/08/2023
• 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