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

Catalog Number	DYNJ45322I
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that chloraprep exploded in pack prior to opening (reoccurring issue).
Additional Manufacturer Narrative
The account reported finding chloraprep leaked, and the customer reported the chloraprep exploded in pack prior to opening.A photo was received for the investigation; the component chloraprep was depicted, the solution had saturated the packaging as the applicator had activated, finished good production records were reviewed with no line down situations, deviations, run-withouts, or non-conformance reports, and the finished good pack build was reviewed.Based on the complaint details, medline confirmed that the chlorapreps had preactivated resulting in the solution saturating the packaging.Cause was documented as mishandling: by mfg.Or can't determine with dc:unknown responsible party; an ecn has been processed to remove section f03-01 from the outer fold and change it to m02-01 to encapsulate the chloraprep to help prevent preactivation, and 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: DBD-TOTAL JOINT PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50713924
• Report Number: 1417592-2026-35662
• Device Sequence Number: 13206303
• Product Code: OJH
• UDI-Device Identifier: 40195327324620
• UDI-Public: 40195327324620
• 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): 09/05/2026

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: DYNJ45322I
• Device Lot Number: 23JMD981
• 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: 01/04/2024
• Initial Report FDA Received Date: 09/10/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown