MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TOTAL JOINT

Catalog Number	DYNJ65240B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "chloraprep that comes in pack seemed to have leaked out of its own package and into pack, contaminating the rest of the pack's contents.".
Additional Manufacturer Narrative
The account reported finding chloraprep preactivated and reported that the chloraprep seemed to have leaked out of its own package and into the pack, contaminating the rest of the pack's contents.No sample or photo was received for the investigation; the packs production record was reviewed and there were no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue, and the bill of materials review found that two chloraprep components are placed in the outerfold of the pack away from the internal components.Without receiving a photo or sample it is unknown what contributed to the reported issue; the reported problem was an unconfirmed defect and the cause was sample required to determine cause.The placement of the chloraprep in the pack was determined to be in a location which provides adequate protection from pre-activation, and the complaint was provided to the vendor for further evaluation while supplier quality 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: TOTAL JOINT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50690718
• Report Number: 1417592-2026-33643
• Device Sequence Number: 5891228
• Product Code: OJH
• UDI-Device Identifier: 40195327163779
• UDI-Public: 40195327163779
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/03/2026

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: DYNJ65240B
• Device Lot Number: 23KBO019
• 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: 04/29/2024
• Initial Report FDA Received Date: 09/09/2026
• 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