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

Catalog Number	DYNJ80900A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bottom of the tyvek pouch has no seal and or it is partially sealed (reference image).This has occurred twice, once this week and once last week.
Additional Manufacturer Narrative
The account reported finding breather pouch not sealed.Photos were received as a sample to aid in the investigation, and the photos received were of the pack inside the breather pouch; finished good production records and finished good pack build were reviewed.While evaluating the received photos, it was clearly observed the breather pouch was not sealed on the manufacturing side, and the reported issue was confirmed.After further evaluation, the issue was likely caused by a manual error in the sealing process during pack assembly; production and qc managers were notified, feedback will be provided to the build team, and the issue will be monitored 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-PERMANENT PACEMAKER PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915430
• Report Number: 1417592-2026-52001
• Device Sequence Number: 14801195
• Product Code: OEZ
• UDI-Device Identifier: 40195327160594
• UDI-Public: 40195327160594
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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: DYNJ80900A
• Device Lot Number: 23GBQ697
• 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: 09/19/2023
• Initial Report FDA Received Date: 09/28/2026
• 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