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

Catalog Number C45031503D-NL

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

The customer stated that the portexadult disposable anesthesia breathing circuits breathing bag failed to hold air after 1 minute into use, no injury to the patient.No additional information was provided.

Manufacturer Narrative

One portex adult disposable anesthesia breathing circuits was received for investigation.The device was received opened and without its original packaging.A review of the device history record, of the reported lot, found no nonconformities or issues during manufacturing.Visual inspection was performed at a distance of 12" to 24" and under normal conditions of illumination.Inspection found no visual defects with the returned devices.During functional testing, the anesthesia breathing circuit and breathing bag were leak tested; no leaks were observed.An audit was conducted on 32 devices from a production lot.The devices were manufactured with the same process procedures as the reported device.The devices were visually inspected and leak tested.No defects were found during the audit of the 32 devices.Investigation was unable to confirm the reported issue and found that the device operated as intended.(b)(4).

• Brand Name: PORTEX®ADULT DISPOSABLE ANESTHESIA BREATHING 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: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5762466
• MDR Text Key: 48573360
• Report Number: 2183502-2016-01291
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: C45031503D-NL
• Device Lot Number: 3163366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1