MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LITHOTOMY PACK

Catalog Number	DYNJ68125C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "all 3 packs had what looked like betadine exploded in them, but the betadine is only on the draping and not in the basins that is comes in.".
Additional Manufacturer Narrative
The customer reported all 3 packs had what looked like betadine exploded in them, and that the betadine was only on the draping and not in the basins that it comes in.Photos were received and reviewed, finished good production records were reviewed, the finished good pack build was reviewed, trending was reviewed, and a stock check was performed with no affected stock found.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: LITHOTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: melinda marquez ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50306794
• Report Number: 1417592-2026-18791
• Device Sequence Number: 21393969
• Product Code: OKV
• UDI-Device Identifier: 40195327390397
• UDI-Public: 40195327390397
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/18/2026

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: DYNJ68125C
• Device Lot Number: 24FBM848
• 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: 10/31/2024
• Initial Report FDA Received Date: 08/18/2026
• 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