MAUDE Adverse Event Report: KING SYSTEMS CORPORATION UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	LC395-6121Z
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elbow gas sampling port on the king/ambu universal breathing circuit came loose after 4-hour procedure and we were unable to re-seat the cap.Previously, this was a luer-lock cap, but it has recently changed by the manufacturer to be a push-on cap.Manufacturer response for circuit, breathing (w connector, adaptor, y piece), universal f2 anesthesia breathing circuit (per site reporter): they will investigate.

• Brand Name: UNIVERSAL F2 ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): KING SYSTEMS CORPORATION; 15011 herriman blvd; noblesville IN 46060
• MDR Report Key: 12804980
• Report Number: 12804980
• Device Sequence Number: 11930484
• Product Code: CAI
• UDI-Device Identifier: 00612649212166
• UDI-Public: (01)00612649212166(11)210910(17)230909(10)100057004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/03/2021
• Report Date (Section F): 11/03/2021

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 Model Number: LC395-6121Z
• Device Catalogue Number: LC395-6121Z
• Device Lot Number: 100057004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2021
• 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: Female
• Patient Weight: 72 KG
• Patient Race: White
• Date Report Sent to FDA: 11/03/2021