MAUDE Adverse Event Report: Medline Industries MEDLINE; DBD-ROBOTIC CABG

Catalog Number	DYNJ83376A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "breather pouch unsealed.".
Additional Manufacturer Narrative
The account reported a "breather pouch - open/incomplete seal." a photo and a physical sample were received for one pack; the tyvek portion was observed completely open, no additional tears or pops were noted, finished good production records and finished good pack build were reviewed, and pack stock check found no issues while component stock check found no inventory.The reported open seal was confirmed by the sample evaluation.It is likely that the pack was mishandled and opened at some point after assembly, and with the information provided medline was not able to confirm at what point the damage occurred; a risk assessment was completed and the incident was found to be acceptable.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-ROBOTIC CABG
• Manufacturer (Section D): Medline Industries; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50265482
• Report Number: 1417592-2026-17781
• Device Sequence Number: 10596334
• Product Code: OEZ
• UDI-Device Identifier: 40195327365784
• UDI-Public: 40195327365784
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/14/2026

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: DYNJ83376A
• Device Lot Number: 23IBU547
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2024
• 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: 05/17/2024
• Initial Report FDA Received Date: 08/16/2026
• 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