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

Catalog Number	DYNDA2752A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "something leaked all over inside the pack making it not useable.".
Additional Manufacturer Narrative
The account reported finding leaking component.Evaluation of the received photo found that one photo was provided, and in the photo you could see brown stains on the bottom portion of the package insert; finished good production records were reviewed and there were no line down situations that might have had an impact on this issue, and finished good pack build was reviewed.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 based on the component's location in the pack it is unlikely that placement contributed to the reported issue.Due to similar reported complaints for this issue, medline is currently working with the component manufacturing facility to further explore root cause and corrective action, and the supplier 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-VAGINAL PREP TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754443
• Report Number: 1417592-2026-39222
• Device Sequence Number: 9241069
• Product Code: OHD
• UDI-Device Identifier: 40193489904681
• UDI-Public: 40193489904681
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: DYNDA2752A
• Device Lot Number: 23BBT653
• 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: 06/20/2023
• Initial Report FDA Received Date: 09/14/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown