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

Catalog Number C45101340-NLJ

Device Problem Leak/Splash (1354)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.No patient involvement.No additional information is available.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.One unit was returned for evaluation of the failure and pictures by the customer were provided.Unit returned was received inside of a plastic bag which is not the original package: samples were 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# 8.0562 (calibration due date 01/2023).Results: the devices don?t present leakage conclusions: based on the leak test results, the reported nonconformance is not confirmed.The cause of the reported problem could not be determined.The lot 4216482 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufactured.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
• Manufacturer (Section G): NULL
• MDR Report Key: 14017042
• MDR Text Key: 288668729
• Report Number: 3012307300-2022-05870
• 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
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 4216482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• 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