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

Catalog Number	DYNJ83877A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "holes in the bags, compromised pack sterility".
Additional Manufacturer Narrative
The customer reported 4 cysto packs had holes in the bags, 2 packs were taken into the or and contaminated everything, and the other 2 were caught on time and returned to supply chain.No sample or photo was received for the investigation; finished good production records, finished good pack build, and trending were reviewed, with no line down situations, no run without approvals, deviations or non-conformance reports, no issues with the build that likely contributed to the reported issue, and 0 additional reported complaints for this issue for the account in the past 6 months.With the information provided, medline was not able to confirm at what point the damage occurred or what may have caused it, and the cause was recorded as sample required to determine cause.Division will monitor for trends.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 TRAY PGYBK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932114
• Report Number: 1417592-2026-53035
• Device Sequence Number: 18532684
• Product Code: FDE
• UDI-Device Identifier: 40195327500796
• UDI-Public: 40195327500796
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/28/2026

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: DYNJ83877A
• Device Lot Number: 24CMB355
• Was Device Available for Evaluation?: No
• 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: 06/12/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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