MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-CYSTO PACK GSWB

Catalog Number	DYNJ59230A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that betadine was busted open in the pack.
Additional Manufacturer Narrative
The customer reported ¿leaking betadine¿ and described the defect as ¿betadine was busted open in the pack¿.A photo was received for the investigation and showed an unopened pack with what looks to be betadine all leaked out on the back table cover; finished good production records were reviewed and no non-conformances were noted, and the finished good pack build was reviewed with no issues that might have an impact on the issue.With the information provided, medline was not able to confirm at what point during the pack's lifecycle the leaking occurred.Based on the component's location in the pack it is unlikely that placement contributed to the reported issue, and the division will monitor for trending.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-CYSTO PACK GSWB
• 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: 50693659
• Report Number: 1417592-2026-34937
• Device Sequence Number: 9595300
• Product Code: FDE
• UDI-Device Identifier: 40195327038947
• UDI-Public: 40195327038947
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/09/2026

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: DYNJ59230A
• Device Lot Number: 23DLA734
• 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: 06/07/2023
• Initial Report FDA Received Date: 09/09/2026
• 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