MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ARTHROSCOPY PACK 180000

Catalog Number	DYNJ65441
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "strikethrough on gown.".
Additional Manufacturer Narrative
The account reported finding strikethrough on gown, and according to the facility in february during a procedure the staff member experienced "strikethrough on their forearms"; the staff member removed the gown, washed, and rescrubbed, and no medical intervention, serious injury, or follow-up care has been reported.Three photos were provided to aid in the investigation; in the first two photos the gown appeared to have some liquid or fluid that had soaked through, the gown information depicted an aami level 4 gown, and additional information from the rep found that the fluid was irrigated normal saline that had been through the patient.Sample evaluation noted the photos depicted part of the inside of one of the sleeves on the gown and the sleeve was noted to discolored which could be shadowing; while photos were provided, medline was not able to confirm a root cause of the issue.The cause was documented as unconfirmed defect/sample required to determine cause, and 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-ARTHROSCOPY PACK 180000
• 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: 50753737
• Report Number: 1417592-2026-39118
• Device Sequence Number: 9195236
• Product Code: OJH
• UDI-Device Identifier: 40193489278812
• UDI-Public: 40193489278812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNJ65441
• Was Device Available for Evaluation?: Yes
• 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: 06/08/2023
• Initial Report FDA Received Date: 09/14/2026
• 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