MAUDE Adverse Event Report: PORTEX; ANESTHESIA BREATHING CIRCUIT

Model Number	450953-NL
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-test, the customers found a roach in the breathing circuit.

• Brand Name: PORTEX
• Common Device Name: ANESTHESIA BREATHING CIRCUIT
• MDR Report Key: 12408973
• Report Number: 3012307300-2021-09055
• Device Sequence Number: 4181395
• Product Code: CAI
• UDI-Device Identifier: 15019315075858
• UDI-Public: 15019315075858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: No Information
• Device Model Number: 450953-NL
• Device Lot Number: 4172570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1