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

Catalog Number	DYNJ76107C
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, we received a report stating an issue was had with a pack of 4 luer lock syringes that were letting air in and leaking out the back stopper area.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2026 prior to patient use the syringes were discovered to have "all the saline drained out of them and just filled with air".The customer reported that after removing the syringes from the table it was additionally discovered "that while pushing the syringe forward and backward, there was air bubbling up along the back stopper".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 (b)(4) on (b)(6) 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-CARDIAC CATH-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sean konrath ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24512777
• Report Number: 1423395-2026-00037
• Device Sequence Number: 18745844
• Product Code: OES
• UDI-Device Identifier: 10195327610272
• UDI-Public: 10195327610272
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: DYNJ76107C
• Device Lot Number: 25ILA399
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2025
• 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