MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-OPEN HEART CDS

Catalog Number	CDS840440T
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that suture boots are splitting when put on.
Additional Manufacturer Narrative
The account reported finding suture boots split putting on instruments.A photo was received for the investigation; the photo depicted two suture boots up close on each end of a forcep, and finished good production records and pack build were reviewed with no issues identified that would have contributed to the reported issue.The reported issue was confirmed through the observation of the separation of the suture boot.The root cause was considered to be a vendor product issue relating to the component manufacturing process; the complaint was provided to the component manufacturing facility for further evaluation, supplier quality will monitor this issue for trending purposes, and there was no report of patient injury or adverse event.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-OPEN HEART CDS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50714013
• Report Number: 1417592-2026-35668
• Device Sequence Number: 9852348
• Product Code: OEZ
• UDI-Device Identifier: 40195327412075
• UDI-Public: 40195327412075
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/07/2026

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: CDS840440T
• 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: 10/30/2024
• Initial Report FDA Received Date: 09/10/2026
• 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