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

Catalog Number C45101316J

Device Problem Leak/Splash (1354)

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

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

A used sample was received to perform an investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A visual inspection of the sample at a distance of 12 inches under normal lighting was performed and found no discrepancies.Functional testing was done using a leak test and it was found that the circuit failed the leak test.The root cause of the reported problem was unable to be determined.A corrective and preventive action (capa) was initiated to address this problem.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during a hospital pre-use check, air leaked from the breathing circuit component.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• 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: jim vegel ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 15457038
• MDR Text Key: 306018587
• Report Number: 3012307300-2022-19824
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: C45101316J
• Device Lot Number: 3892065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1