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

Catalog Number	DYNJ56529
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "last friday all the lower extremity packs we used had this ¿moist¿ spot on the drape".The reporter stated, "to me, it felt more like a lubricant of some kind since it had an oily sensation when rubbed between my fingers".
Additional Manufacturer Narrative
The customer reported a "moist" spot on the drape and stated it "felt more like a lubricant of some kind since it had an oily sensation when rubbed between my fingers." a photo was received for investigation; the photo shows the extremity drape, no other pack contents were seen, and medline observed what looks to be an oily substance on the krayton material of the drape.The reported problem was confirmed based on the photo evaluation.Based on the complaint details and review of the bill of materials, there is a bulb syringe within the same area of the pack as the reported issue, the drape contains a krayton material around the fenestration, and contact between these components can sometimes create an oily appearance; 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-LOWER EXTREMITY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755075
• Report Number: 1417592-2026-39341
• Device Sequence Number: 21181121
• Product Code: OJH
• UDI-Device Identifier: 40889942652663
• UDI-Public: 40889942652663
• 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): 09/11/2026

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: DYNJ56529
• 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: 07/20/2023
• Initial Report FDA Received Date: 09/14/2026
• 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