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

Catalog Number	DYNJT3751
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the angio drape provided in the pack it super self adhered to itself.Unfolding it sterile is impossible to do without heavy assistance from the tech in the room.".
Additional Manufacturer Narrative
The account reported that the fem angio drape was "a lot tackier/sticky" and that the team had to use several techs to assist with unfolding the drape.A photo and a sample were received for the investigation, including a video and a physical sample for one unused drape; the rest of the pack was not available, and finished good production records and finished good pack build were reviewed with no issues identified that contributed to the reported issue.Based on review of the video and physical sample, the drape exhibited resistance during handling and, upon unfolding, the adhesive was difficult to separate without damaging the component.The root cause is considered to be a vendor product issue relating to the component manufacturing process, and the division 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-CATH PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931147
• Report Number: 1417592-2026-52858
• Device Sequence Number: 10759197
• Product Code: OES
• UDI-Device Identifier: 10198459350986
• UDI-Public: 10198459350986
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/09/2026

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: DYNJT3751
• Device Lot Number: 25FBL081
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2025
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/29/2026
• 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