MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CARDIAC CATH

Catalog Number	DYNJ45524B
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the syringe within the pack "has a "neck", meaning that it has extra space that allows for bubbles if not careful." the customer reported that they had "several cases where an air bubble was sent down the coronary artery", and "in one procedure, the air bubble did not dissipate and was still present at the end of the case".The customer reported there were no complications during or after the procedures as a result of the air bubble.The customer did not report any serious injury or medical intervention as a result of the reported issue.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.
Event or Problem Description
It was reported that the syringe within the pack "has a "neck", meaning that it has extra space that allows for bubbles if not careful." the customer reported that they had "several cases where an air bubble was sent down the coronary artery", and "in one procedure, the air bubble did not dissipate and was still present at the end of the case".

• Brand Name: MEDLINE
• Common Device Name: CARDIAC CATH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24278911
• Report Number: 1423395-2026-00020
• Device Sequence Number: 8318442
• Product Code: OES
• UDI-Device Identifier: 10193489853780
• UDI-Public: 10193489853780
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ45524B
• Device Lot Number: 25IBL872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown