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

Catalog Number	DYNJ68411B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿arrived opened along the heat seal.¿.
Additional Manufacturer Narrative
The account reported finding open seal.Finished good production records were reviewed, and there were no line downs, deviations or non-conformance reports that might have had an impact on this issue; finished good pack build was reviewed, and there are no issues with the build that likely contributed to the reported issue.A physical sample for one pack was received, and the tyvek seal was observed open along the top middle of the bag, confirming the reported issue; a white line running along the edge seam indicated that the pouch did go through the sealing machine and was closed at some point in time.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-CYSTO 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: 50233795
• Report Number: 1417592-2026-16446
• Device Sequence Number: 18726049
• Product Code: FDE
• UDI-Device Identifier: 40195327341313
• UDI-Public: 40195327341313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2026

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: DYNJ68411B
• Device Lot Number: 24CBL852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2024
• 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: 08/21/2024
• Initial Report FDA Received Date: 08/13/2026
• 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