MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LAP CHOLE

Catalog Number	DYNJ907687G
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "received an empty anti fog solution bottle in a lap chole pack".
Additional Manufacturer Narrative
The account reported finding antifog bottle empty in a lap chole pack.A photo and a sample were received for investigation; the photo shows the pack insert along with the antifog solution and pad, and the sample received consisted solely of the antifog bottle.Upon evaluation, the bottle was intact, the cap was tightly fastened, but the bottle was empty, confirming the reported issue.The root cause is considered to be a vendor-related issue stemming from the component¿s manufacturing process, as this component arrives pre-sealed in its original vendor packaging and undergoes no further manipulation during the assembly process; this complaint has been 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: LAP CHOLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50698695
• Report Number: 1417592-2026-35397
• Device Sequence Number: 14925529
• Product Code: FDE
• UDI-Device Identifier: 10198459060403
• UDI-Public: 10198459060403
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2026

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: DYNJ907687G
• Device Lot Number: 25CLA886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2025
• 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: 06/05/2025
• Initial Report FDA Received Date: 09/09/2026
• 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