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

Catalog Number	DYNJ84416
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it looks like the heat weld failed and the sms separated from the plastic.The other complaint is that the adhesive on the chest incision incise window does not stick to the skin well.".
Additional Manufacturer Narrative
The account reported that the cv incise drape failed during surgery, the sms separated from the plastic, and the adhesive on the chest incision incise window does not stick to the skin well.A photo and a sample were received for investigation; the pictures show separation between the grey pe material and the base material, the sample was reviewed and there was separation between the two materials, finished good production records had no non-conformances, and there were no issues with the pack build.The separation between the two materials was confirmed, while the adhesive issue with the drape was reviewed and the adhesive was found to meet the product specifications.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process; it was reported that there was no impact to the patient, staff or procedure, and no medical intervention, serious injury, or follow-up care has been reported.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 PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: urmi parekh ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855260
• Report Number: 1417592-2026-47672
• Device Sequence Number: 13250140
• Product Code: OEZ
• UDI-Device Identifier: 40195327363292
• UDI-Public: 40195327363292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2026

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: DYNJ84416
• Device Lot Number: 23EBM662
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2023
• 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: 08/23/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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