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

Catalog Number	DYNJ55052D
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer received pack not sealed.
Additional Manufacturer Narrative
The account reported finding pack not sealed.A photo and a sample were received; one pack was evaluated, and along the edge of the tyvek end the seal came apart and is completely open almost the entire edge length, with no other damage noted to the pouch.Finished good production records and finished good pack build were reviewed with no non-conformances or issues noted, and component and branch stock checks found no defects; technipaq reviewed customer provided samples, retain samples from each manufacturing lot, and historical spc data.With the sample provided, medline was unable to confirm the issue and determine a root cause, and technipaq was unable to confirm that the defect occurred as a result of inadequate manufacturing; supplier quality 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-SET UP PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899056
• Report Number: 1417592-2026-51095
• Device Sequence Number: 16142056
• Product Code: LRO
• UDI-Device Identifier: 40195327145713
• UDI-Public: 40195327145713
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/24/2026

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: DYNJ55052D
• Device Lot Number: 22KMD039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2023
• 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: 03/15/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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