MAUDE Adverse Event Report: PORTEX; BREATHING-CIRCUIT

Catalog Number C45101344-NLJ

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, leakage of air from the anesthesia circuit was detected.No patient involvement.

Event Description

Investigation completed and summary in h 10.

Manufacturer Narrative

Investigation completed on a smiths medical breathing|portex general anesthesia circuits.Pictures were attached which revealed no damage to the device.Sample product from p/n c45101344-nlj, l/n 3986652 was tested using procedure mp 2025 rev.122.The device passed testing.Production revealed 100% passing of testing prior to release unknown cause of event, as device passed leakage testing.

• Brand Name: PORTEX
• Type of Device: BREATHING-CIRCUIT
• MDR Report Key: 11105166
• MDR Text Key: 224741841
• Report Number: 3012307300-2021-00021
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/07/2023
• Device Catalogue Number: C45101344-NLJ
• Device Lot Number: 3986652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1