MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SIH BASIC ROBOT

Catalog Number	DYNJ903717P
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "pack came in unsealed".
Additional Manufacturer Narrative
The account reported finding open vendor seal.A photo and a physical sample for one opened pack were received, and medline observed the vendor seal was opened; finished good production records and finished good pack build were reviewed, with no issues identified that contributed to the reported issue.Based on the photos and physical sample provided, medline observed that the breather pouch seal was opened.The pouch displayed evidence of having been sealed at some point, but medline was unable to confirm whether this occurred during handling, storage or transit; 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-SIH BASIC ROBOT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50234815
• Report Number: 1417592-2026-16610
• Device Sequence Number: 21397856
• Product Code: OHD
• UDI-Device Identifier: 10198459143175
• UDI-Public: 10198459143175
• 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): 08/13/2026

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: DYNJ903717P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2025
• 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: 07/09/2025
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (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