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

Catalog Number	DYNJ80199A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tubing is very hard and stiff and it cracks/leaks under pressure while connected to the klein pump that they are using during the vein ablation procedures.".
Additional Manufacturer Narrative
The customer reported hundreds of failures of the tbg pump tumescent w/spike component and that the tubing is very hard and stiff and it cracks/leaks under pressure while connected to the klein pump during the vein ablation procedures.No sample or photo was received for the investigation; finished good production records were unable to be reviewed due to no lot number being provided, and the finished good pack build was reviewed with no issues with the build that likely contributed to the reported issue.Per the complaint details, medline was unable to confirm the reported issue due to not receiving a sample or photo.The cause was documented as sample required to determine cause, and the complaint was provided to the vendor for further evaluation while supplier quality 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-VEIN PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50773498
• Report Number: 1417592-2026-40595
• Device Sequence Number: 21204287
• Product Code: OEZ
• UDI-Device Identifier: 40195327040865
• UDI-Public: 40195327040865
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/10/2026

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: DYNJ80199A
• 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: 01/27/2023
• 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