MAUDE Adverse Event Report: MEDLINE - NAMIC; MTS,STANDARD,3V,KIT-ST. PETER HOSP

Catalog Number	60160514
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility there was a manifold/syringe connection issue.There was no further information.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 (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.
Event or Problem Description
According to the facility there was a manifold/syringe connection issue.
Additional Manufacturer Narrative
At the time of the reported manifold/syringe connection issue, the reporting facility indicated a concern that the event "could have caused an issue with injecting air into the arterial system while performing a lv gram the settings were 10/30@900 psi" and that "these settings are normal and standard." to date, no report of death, serious injury, medical intervention, follow-up care, or other adverse health impact has been reported.Additionally, an update was made to: e1.

• Common Device Name: MTS,STANDARD,3V,KIT-ST. PETER HOSP
• Manufacturer (Section D): MEDLINE - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20613679
• Report Number: 3015910259-2024-00043
• Device Sequence Number: 12988086
• Product Code: OEZ
• UDI-Device Identifier: 20193489048817
• UDI-Public: 20193489048817
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 03/19/2026

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: 60160514
• Device Lot Number: 24IBH205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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