MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-CATH LAB TRAY

Catalog Number	DYNJ83940C
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, angie drape is too sticky, sticking to the drape itself and really sticking on patient making it almost impossible to remove without skin damage.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, angie drape is too sticky, sticking to the drape itself and really sticking on patient making it almost impossible to remove without skin damage.

• Brand Name: MEDLINE
• Common Device Name: DBD-CATH LAB TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25100563
• Report Number: 1423395-2026-00131
• Device Sequence Number: 13259651
• Product Code: OES
• UDI-Device Identifier: 10198459449109
• UDI-Public: 10198459449109
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ83940C
• Device Lot Number: 26AMF861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown