MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GM HEART CATH II PACK-LF

Catalog Number	DYNJ0621599AG
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update to d9: sample returned.Update to h3: sample evaluated.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.
Additional Manufacturer Narrative
Update to d4: expiration date.Update to h4: manufacturing date.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025 while setting up for a procedure the "syringe popped off and would not lock back in".The customer reported there was no patient involvement and the procedure was completed with an alternate device.No additional details are available related to the customer 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 on (b)(6) 2025, while setting up for a procedure the "syringe popped off and would not lock back in".

• Common Device Name: GM HEART CATH II PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22320190
• Report Number: 1423395-2025-00062
• Device Sequence Number: 18346040
• Product Code: OES
• UDI-Device Identifier: 10195327638467
• UDI-Public: 10195327638467
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: DYNJ0621599AG
• Device Lot Number: 25CMC617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 07/08/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 06/24/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2025
• 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