MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-NEURO ANGIO DRAPE TRAY

Catalog Number	DYNJ87924
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that items were put in this pack that the customer did not agree upon as part of the pack.Injection tubing for the power injector is leaking as well.
Additional Manufacturer Narrative
The account reported finding incorrect items and leaking tubing.Three cases were received to aid in the investigation; the packs were opened and the tubing was reviewed, visual inspection noted no discrepancies, no cracks, holes or other defects were noted, and water was run through the tubing with no leaking noted at any point.Therefore, the defect reported could not be confirmed with the sample provided.Based on the review of the samples provided, medline was unable to replicate the reported issue of the injection tubing for the power injector leaking, and after reviewing the pack history was not able to determine what components were incorrect within the pack as no changes were noted between the revisions of the pack.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-NEURO ANGIO DRAPE TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50592003
• Report Number: 1417592-2026-31798
• Device Sequence Number: 15815297
• Product Code: OJG
• UDI-Device Identifier: 40198459078829
• UDI-Public: 40198459078829
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/03/2026

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: DYNJ87924
• Device Lot Number: 24IBE711
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• 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