MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAIN INJECTION TRAY

Catalog Number	DYNJRA2303
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "pain kits that were delivered with punctures in the plastic.".
Additional Manufacturer Narrative
The account reported finding "punctures on plastic pouch." a photo and a sample were received for investigation; sample and photo both have damaged on the plastic pouch of the packaging, finished good production records were reviewed with no line down situations, run without approvals, substitutions, deviations or non-conformance reports that might have had an impact, and pack build history had no issues that would contribute to the reported issue.The reported issue was confirmed.Based on the complaint details, the pack was caught or snagged on an outside source at some point during production, transit or storage, and with the information provided, medline was not able to confirm at what point the damage occurred; 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: PAIN INJECTION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853009
• Report Number: 1417592-2026-47294
• Device Sequence Number: 18625909
• Product Code: OFT
• UDI-Device Identifier: 10195327519209
• UDI-Public: 10195327519209
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: DYNJRA2303
• Device Lot Number: 24KBU042
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2025
• 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: 03/17/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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