MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-ARTERIOGRAM PACK

Catalog Number	DYNJ40471F
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, the tip of the white syringe broke when trying to remove.This occurred during set up, not during patient use.
Additional Manufacturer Narrative
According to the facility, the tip of the white syringe broke when trying to remove.This occurred during set up, not during patient use.No additional information at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: MEDLINE
• Common Device Name: DBD-ARTERIOGRAM PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; three lakes dr; northfield, IL 60093 ; 2173279112
• MDR Report Key: 24484194
• Report Number: 1423395-2026-00034
• Device Sequence Number: 20106780
• Product Code: OES
• UDI-Device Identifier: 10198459401527
• UDI-Public: 10198459401527
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/02/2026

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: DYNJ40471F
• Device Lot Number: 25IBJ780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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