MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; MTS,RHK,DEPT,OF VETERANS,AFFAIRS

Catalog Number	60042271
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility the control syringe is not correctly threading onto the transducer allowing air into the system.Per the facility there was no harm or serious injury to any patient.No additional information was made available at this time.A sample was returned for evaluation, and a definitive root cause could not be determined at this time.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 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 the control syringe is not correctly threading onto the transducer allowing air into the system.

• Common Device Name: MTS,RHK,DEPT,OF VETERANS,AFFAIRS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21263913
• Report Number: 3015910259-2025-00004
• Device Sequence Number: 13114911
• Product Code: OEZ
• UDI-Device Identifier: 20193489043126
• UDI-Public: 20193489043126
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/29/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60042271
• Device Lot Number: 0000131358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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