MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-POSTERIOR HIP

Catalog Number	DYNJ909642D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿we have another leaking hotline¿ and ¿the blue rubber stopper doesn't fully close.¿.
Additional Manufacturer Narrative
The customer reported a leaking hotline and that the blue rubber stopper doesn't fully close.A photo of the component packaging and the component itself was received; the blue rubber stopper appeared fully inserted, no cracks were seen on the connection or visible portion of the tubing, no visual defects were observed, device history records were reviewed with no non-conformances noted, and the pack build was reviewed with no issues identified that would likely contribute to the reported issue.Based on the photo provided and without the physical sample, medline was unable to confirm the reported issue or determine a root cause, as no defects were observed in the image; the vendor reviewed the manufacturing records and confirmed all specifications were met and reviewed the provided photos and confirmed leaking but was unable to determine further conclusions with the lack of sample availability.The division 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-POSTERIOR HIP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50904041
• Report Number: 1417592-2026-51496
• Device Sequence Number: 6037790
• Product Code: OJH
• UDI-Device Identifier: 10198459250040
• UDI-Public: 10198459250040
• 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): 09/25/2026

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: DYNJ909642D
• Device Lot Number: 25HBR652
• 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: 11/13/2025
• Initial Report FDA Received Date: 09/25/2026
• 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