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

Catalog Number C45101340-NLJ

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Only the month ((b)(6)) and year (2020) of the event date are known.(b)(6).

Event Description

It was reported that during a pre-use check, the customer noticed that air was leaking from the portex general anesthesia circuit.There was no patient involvement.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 2-3-2 kamiochiai, chuoh-ku,; minneapolis, MN 55442
• MDR Report Key: 10945722
• MDR Text Key: 219502355
• Report Number: 3012307300-2020-12101
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/12/2023
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 3986649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1