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

Catalog Number	60160514
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "rotating adaptor separated from the manifold while injecting air into the arterial system".No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
Rotating adaptor separated from the manifold while injecting air.
Additional Manufacturer Narrative
Updates made to: d3, e1, e2, e3.

• Common Device Name: DBD-MTS,STANDARD,3V,KIT-ST. PETER HOSP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 20589881
• Report Number: 3015910259-2024-00042
• Device Sequence Number: 12401773
• Product Code: OEZ
• UDI-Device Identifier: 20193489048817
• UDI-Public: 20193489048817
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 60160514
• Device Lot Number: 24IBH205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 03/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown