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

Catalog Number	DYNJ60699A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "received pvp solution broken in custom pack leaking everywhere inside.".
Additional Manufacturer Narrative
The customer reported receiving pvp solution broken in custom pack leaking everywhere inside, with the location of concern "in tray at the bottom"; the incident did not occur during patient use.The investigation included sample evaluation, review of finished good production records, review of finished good pack build, trending review, and stock check; two full opened packs were evaluated and it was observed the pvp solution had leaked throughout the entire pack, and the pvp paint cap was fully tightened.Based on the complaint details, sample evaluation, and investigation, medline confirmed the betadine leaked inside of the pack.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, and is working with the component manufacturing facility to further explore root cause and corrective action.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
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856375
• Report Number: 1417592-2026-47866
• Device Sequence Number: 10026467
• Product Code: MLS
• UDI-Device Identifier: 40195327023073
• UDI-Public: 40195327023073
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/22/2026

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: DYNJ60699A
• Device Lot Number: 23DMC314
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/26/2023
• 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: 07/20/2023
• Initial Report FDA Received Date: 09/22/2026
• 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