MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SOLUTION,SALINE,IRRGATION,500ML,STRL

Catalog Number	DYND500MLS
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sealant under the cap is very hard to remove and therefore is causing sterility concerns and issues with particles falling into the sterile liquid.
Additional Manufacturer Narrative
It was reported that ¿the seal was very hard to remove and causing sterility concerns and issues with particles falling into the sterile liquid.Medline quality received two samples; one bottle was empty and the seal was already removed and the cap off, with white particles at the bottom of the bottle and residue around the lid where the seal had been removed, and the second bottle was fully intact but the seal would not lift except for one small corner by the edge of the pull n¿ peel tab.As a result, medline was able to confirm the complaint.¿ 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: SOLUTION,SALINE,IRRGATION,500ML,STRL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: durga duduku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50821588
• Report Number: 1417592-2026-45052
• Device Sequence Number: 18692478
• Product Code: FRO
• UDI-Device Identifier: 40884389118406
• UDI-Public: 40884389118406
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K083042
• 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): 09/17/2026

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: DYND500MLS
• Device Lot Number: 22114393
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2023
• 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: 03/15/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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