MAUDE Adverse Event Report: MEDLINE - NAMIC; DBD-MTO,3 VALVE,KIT,V.A MED CEN,PORTL,AN

Catalog Number	652210516
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Syringe loosened from connection.
Additional Manufacturer Narrative
It was reported that the syringe would not stay tight and slowly loosened, allowing air into the system.This was noted before use during set up of the system.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Updated d3, h4, h6.

• Common Device Name: DBD-MTO,3 VALVE,KIT,V.A MED CEN,PORTL,AN
• Manufacturer (Section D): MEDLINE - NAMIC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21401526
• Report Number: 3015910259-2025-00009
• Device Sequence Number: 21226569
• Product Code: OEZ
• UDI-Device Identifier: 10193489076868
• UDI-Public: 10193489076868
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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?: No
• Device Catalogue Number: 652210516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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