MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LOVELACE UNIVERSAL PACK

Catalog Number	DYNJ68608B
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wet on top of basin".
Additional Manufacturer Narrative
It was reported that the finding moisture on top of basin.Medline reviewed the finished good production records and there were no line down situations, deviations, run-without, or non-conformance reports that might have had an impact on this issue; the finished good pack build was reviewed, and none of the components placed within the ring basin could have contributed to the reported moisture including the remainder of the components within the pack.Medline was not able to confirm the reported moisture on basin as there were no samples or a detailed picture that depicted the issue received for this complaint investigation.Without a sample it is difficult to determine a true root cause for the reported issue; the supplier quality team 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: DBD-LOVELACE UNIVERSAL PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883775
• Report Number: 1417592-2026-49881
• Device Sequence Number: 13202117
• Product Code: LRO
• UDI-Device Identifier: 40195327498161
• UDI-Public: 40195327498161
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/23/2026

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: DYNJ68608B
• Device Lot Number: 24HMG326
• 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: 12/06/2024
• Initial Report FDA Received Date: 09/24/2026
• 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