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

Catalog Number	DYND500MLS
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "ripped seal while opening.Would consider not sterile adhesive and or seal over the lip of the bottle.We would not consider this not sterile.White adhesive residue on lip of bottle.Is that sterile?".
Additional Manufacturer Narrative
The account reported finding ¿ripped seal while opening,¿ ¿adhesive and or seal over the lip of the bottle,¿ and ¿white adhesive residue on lip of bottle.¿ a photo was received for the investigation, and photographs were submitted; pictures shows the incomplete seals, but due to not having the actual sample, medline was not able to conduct a proper investigation.The reported complaint was confirmed with the pictures provided.Based on the sample and complaint details, the root cause is considered to be a vendor product issue relating to the manufacturing process; the vendor investigation stated the most likely root cause is the ¿bottle were not processed through the induction sealer at normal line speed,¿ and there has been no change to the reportability decision associated with this 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: pranayreddy alluri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50693428
• Report Number: 1417592-2026-34913
• Device Sequence Number: 5891319
• Product Code: FRO
• UDI-Device Identifier: 40884389118406
• UDI-Public: 40884389118406
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/07/2026

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: 24078106
• Was Device Available for Evaluation?: No
• 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: 08/29/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown