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

Catalog Number	DYNJ04529L
Medical Device Problem Codes	Retraction Problem (1536); Unintended Movement (3026); Physical Resistance/Sticking (4012); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, it was reported that the syringe plunger can become stuck and is difficult to pull back.The facility noted that the black plunger component inside the syringe may flip upside down during retraction.The customer also reported that when pulling back to draw fluid, the syringe appears to draw air instead of fluid, and physicians have experienced resistance during radial access procedures.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
According to the facility, it was reported that the syringe plunger can become stuck and is difficult to pull back.The facility noted that the black plunger component inside the syringe may flip upside down during retraction.The customer also reported that when pulling back to draw fluid, the syringe appears to draw air instead of fluid, and physicians have experienced resistance during radial access procedures.

• Brand Name: MEDLINE
• Common Device Name: CARDIAC CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24085760
• Report Number: 1423395-2026-00012
• Device Sequence Number: 9895515
• Product Code: OES
• UDI-Device Identifier: 10198459391460
• UDI-Public: 10198459391460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/15/2026

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: DYNJ04529L
• Device Lot Number: 25JLA868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2025
• 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