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

Catalog Number	DYNJV0155X
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "manifold rotating adaptor blows off during injections," "contrast tubing has kinks/damaged tubing," "another damaged contrast line," "manifold leaking air," "2 manifolds with severely damaged contrast tubing," and "more damaged contrast tubing.".
Additional Manufacturer Narrative
The account reported finding kinked tubing and defective manifold.A photo was received of the reported kinked tubing; finished good production records and the finished good pack build were reviewed, and there were no line down situations, run without approvals, deviations or non-conformance reports that might have had an impact on this issue.Based on review of the supplied photo, the kinked/compressed tubing is confirmed; no photo or sample was received for the defective manifold, thus, we cannot confirm this report.Root cause of the reported kinked tubing can be attributed to tubing developing kinks, or compressed/flattened spots, as it rests against itself or other components within the pouch, during shipment and storage, and 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-CARDIAC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884995
• Report Number: 1417592-2026-50118
• Device Sequence Number: 10664283
• Product Code: OEZ
• UDI-Device Identifier: 10198459225239
• UDI-Public: 10198459225239
• 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): 09/23/2026

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: DYNJV0155X
• Device Lot Number: 25CME617
• 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: 08/07/2025
• Initial Report FDA Received Date: 09/24/2026
• 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