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

Catalog Number	DYNJ69324B
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tbg insufflation suct whtie (insufflation tubing) not fitting into wall suction.- improper substitute.
Additional Manufacturer Narrative
The account reported tbg insufflation suct whtie (insufflation tubing) was not fitting into wall suction and the end of the tubing is not compatible with their devices or wall hook ups.A photo was received for the investigation; the photo shows only a white tip, but no tubing, finished good production records were reviewed with no non-conformances noted, and the finished good pack build was reviewed with no issues that might have an impact on the issue.After further review, the photo of the white tip the account sent in is not in this kit's bill of materials, and to confirm this is an assembly issue, the full tubing component would be needed.The cause code was adjusted to unconfirmed defect with item not in kit bom, and the division will monitor for trending.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-HEART VALVE PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joyce qiu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50550339
• Report Number: 1417592-2026-30030
• Device Sequence Number: 10601085
• Product Code: OEZ
• UDI-Device Identifier: 40195327298280
• UDI-Public: 40195327298280
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/01/2026

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: DYNJ69324B
• Device Lot Number: 23JBP477
• 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: 12/28/2023
• Initial Report FDA Received Date: 09/01/2026
• 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