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

Catalog Number	DYNJ64242B
Medical Device Problem Codes	Moisture Damage (1405); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "wet packs potentially used on patient.".
Additional Manufacturer Narrative
The account reported finding wet packs; more information stated the delivery person left some cases of this product outside while it was raining at the facility, the facility sent it back to medline, and the account received them again.No sample or photo was received for the investigation; finished good production records were reviewed and no non-conformances were noted, the finished good pack build was reviewed, trending was reviewed, and a stock check found no inventory left of this remaining lot at the branch.The reported problem could not be evaluated by sample or photo; based on the complaint details medline determined that the reported damage occurred after kit assembly during transit or storage of the pack.Given this the root cause is considered an operations service issue; per the facility the device was not used on a patient and therefore no patient involvement, and there was no serious injury identified, follow up care needed or medical intervention reported related to the incident.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-ARTHROSCOPY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773269
• Report Number: 1417592-2026-40556
• Device Sequence Number: 9471954
• Product Code: OJH
• UDI-Device Identifier: 40193489956406
• UDI-Public: 40193489956406
• 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): 09/14/2026

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: DYNJ64242B
• Device Lot Number: 22HMD098
• 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: 03/13/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown