MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	370900-NL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Disposable anesthesia breathing circuit failed compliance tests multiple times after using 3 circuits from same lot number.When manual leak test performed, circuit would only hold pressure if apl was set to 40cmh2o or greater.When circuit was released below 40cmh2o breathing circuit would not remain pressurized.

• Brand Name: PORTEX
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 13994664
• Report Number: 13994664
• Device Sequence Number: 4432397
• Product Code: CAI
• UDI-Device Identifier: 15019315076169
• UDI-Public: (01)15019315076169
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/07/2022
• Report Date (Section F): 02/07/2022

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: Other
• Device Model Number: 370900-NL
• Device Lot Number: 4172906
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2022
• 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
• Date Report Sent to FDA: 02/07/2022