MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-VAGINAL DELIVERY PACK

Catalog Number	DYNJ35455G
Medical Device Problem Codes	Fluid/Blood Leak (1250); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we continue to get vaginal delivery pack with leaks.".
Additional Manufacturer Narrative
The account reported finding leaking pvp.A photo and a sample were received for investigation; the photos showed or towels atop a pvp bottle that had leaked, brown staining on the or towels, and the bottle appeared to be crushed, and the returned pack showed pvp had stained or towels placed directly above it as well as a corner of the tray.The bottle was found to be dented and the cap was noted to be placed on tightly, and the pack production record review found no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue.The reported leaking was confirmed, but with the information provided, medline was not able to confirm at what point during the pack's lifecycle the leaking occurred or what may have caused it; the complaint was provided to the component manufacturing facility for further evaluation 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-VAGINAL DELIVERY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50775406
• Report Number: 1417592-2026-40840
• Device Sequence Number: 15808678
• Product Code: MLS
• UDI-Device Identifier: 40195327214440
• UDI-Public: 40195327214440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/11/2026

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: DYNJ35455G
• Device Lot Number: 22HBY914
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/15/2023
• 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: 02/10/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (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