MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-VAG INTERMEDIATE PPP

Catalog Number	DYNJ54767D
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "broken chloraprep stick in vaginal intermediate pack".
Additional Manufacturer Narrative
The account reported finding a preactivated chloraprep after the complaint described a broken chloraprep stick in a vaginal intermediate pack.A photo was provided for investigation and shows an unwrapped back table cover stained from the orange chloraprep solution, with the closed packaging and sponge also stained; finished good production records were reviewed and there were no line down situations, runs without approvals, deviations, or non-conformance reports that might have had an impact, and the finished good pack build confirmed the component is placed on top of the outer ring of the basin, which is full of components, and remains packaged.The reported problem was confirmed based on the photo, and the investigation found the component placement was not optimal but did not likely contribute to the defect on its own based on lack of trending.The likely root cause is mishandling at some point in the pack's lifecycle, though the specific point could not be determined; the component's placement could be changed to the inside of the basin for further protection, and 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: DBD-VAG INTERMEDIATE PPP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915302
• Report Number: 1417592-2026-51989
• Device Sequence Number: 5330464
• Product Code: OJF
• UDI-Device Identifier: 40195327021109
• UDI-Public: 40195327021109
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/10/2026

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: DYNJ54767D
• Device Lot Number: 23FBN036
• 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: 10/11/2023
• Initial Report FDA Received Date: 09/28/2026
• 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