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

Catalog Number	DYNJ64242B
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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 wet packs, and the customer stated that the shipment arrived wet with some boxes completely soaked and that a few weeks later they received some of the damaged item back as a regular order.Medline's investigation received no sample or photo, reviewed the finished good production records, finished good pack build, complaint history, and current stock; no non-conformances were noted that would have contributed to the reported issue, placement was unlikely to have contributed, and no inventory remained 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, and 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; there was no serious injury identified, follow up care needed or medical intervention reported related to the incident, and the division will monitor for trending.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: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773856
• Report Number: 1417592-2026-40623
• Device Sequence Number: 18795342
• 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): 09/10/2026

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: 03/31/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (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