MAUDE Adverse Event Report: NULL PORTEX DISPOSABLE ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Lot Number 4074046

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Sample was submitted to leak test inspection per specification qp 2025 rev.104 disposable anesthesia breathing circuit (dabc) / section 1.8 leak test.Leak test results: leak test inspection was performed on the returned device using equipment manometer id# 8.0581 (calibration due date 01/2022).Results: the device doesn't present leakage.Conclusions: based on the leak test results, the reported nonconformance is not confirmed.Root cause: root cause cannot be addressing since the failure mode reported is not confirmed action taken: no corrective actions were taken since the investigation did not reveal the failure reported.

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.No patient injury was reported.

• Brand Name: PORTEX DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 13456914
• MDR Text Key: 287610166
• Report Number: 3012307300-2022-02596
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Lot Number: 4074046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1