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

Catalog Number	DYNJ63435D
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	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tape used to package the custom pack was taped over a tray and caused a tear to the packaging film and compromised the sterile components inside.".
Additional Manufacturer Narrative
The customer reported that the case was not damaged or appeared to be re-packaged; however, the tape used to package the custom pack was taped over a tray and caused a tear to the packaging film and compromised the sterile components inside.A photo and one full, unopened pack were received; the photo was reviewed, the returned sample was evaluated, finished good production records were unable to be reviewed as no lot number was provided, the finished good pack build was reviewed, and trending was reviewed.Medline confirmed the reported issue of the fold tite pouch having a hole, and there was no damage to the cmpj pack inside the fold tite, ensuring that there were no sterility concerns with the pack.Further assessment indicates that the pack was likely caught and snagged on an external source at some point during production, transit, or storage; however, the information provided does not allow determination of the exact timing of the damage, and cds fold-tite pouches do not establish sterility and are strictly intended to provide a protective covering for the pack contents.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: CYSTO PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931920
• Report Number: 1417592-2026-52978
• Device Sequence Number: 13183853
• Product Code: FDE
• UDI-Device Identifier: 40195327522156
• UDI-Public: 40195327522156
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: DYNJ63435D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2024
• 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: 11/15/2024
• Initial Report FDA Received Date: 09/29/2026
• 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