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

Catalog Number	DYNJ84154
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "leaking pvp.".
Additional Manufacturer Narrative
The account reported finding leaking pvp, and the specific pvp component that leaked was not indicated in the complaint.No sample or photo was received for the investigation; finished good production records were unable to be reviewed as no lot number was provided, and a review of the pack build was completed with no issues with the build that likely contributed to the reported issue.Due to not receiving a physical sample or photo, medline was not able to confirm if there was a problem with the seal or bottle causing the leak or if it may have been crushed.However, due to similar reported complaints for this issue, it was determined that a molding defect within the cap was the cause of the leaking, and the complaint was provided to the component manufacturing facility for further evaluation.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-ROBOTIC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50777901
• Report Number: 1417592-2026-41218
• Device Sequence Number: 10754791
• Product Code: OHD
• UDI-Device Identifier: 40195327337132
• UDI-Public: 40195327337132
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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: DYNJ84154
• 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: 10/19/2023
• Initial Report FDA Received Date: 09/15/2026
• 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