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

Catalog Number	DYNJ30955N
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the dressing has weak adhesive".
Additional Manufacturer Narrative
The customer reported that the dressing has weak adhesive; the issue did not occur during patient use and no injury occurred.No sample or photo was received for the investigation; device history records were reviewed with no non-conformances noted, and the bill of materials and pack build were reviewed with no issues identified that would likely contribute to the reported issue.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided.The cause was unconfirmed, with sample required to determine cause, and the division will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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: CATH LAB PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913767
• Report Number: 1417592-2026-51836
• Device Sequence Number: 17586960
• Product Code: OES
• UDI-Device Identifier: 10198459433108
• UDI-Public: 10198459433108
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: DYNJ30955N
• Device Lot Number: 25GBP236
• 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: 11/25/2025
• Initial Report FDA Received Date: 09/28/2026
• 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