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

Model Number C37201370J

Device Problem Leak/Splash (1354)

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

Event Date 12/01/2019

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, leakage of air was observed in the anesthesia circuit.No patient injury was reported.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation in used condition and without its original packaging.Visual and functional testing were performed.Visual inspection found a pinhole in the corrugated tube.Functional testing found the circuit did not pass the leak test.The root cause of the issue could not be determined.A capa (corrective and preventative action) was issued in order to determine the root cause and implement proper corrective actions.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX
• 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; 2, 2-jou kudaru, kawaharamachi; minneapolis, MN 55442
• MDR Report Key: 15280159
• MDR Text Key: 305160981
• Report Number: 3012307300-2022-15953
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10351688434067
• UDI-Public: 10351688434067
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C37201370J
• Device Catalogue Number: C37101307J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• 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