MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX® BLUE LINE UNCUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/133/060

Device Problem Detachment Of Device Component (1104)

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

It was reported that the connector's tube is easily removable.No other information is available at this time.No patient information available.

Manufacturer Narrative

The returned sample was given functional testing.During testing the device was connected with a ventilator circuit and ventilated by heated humidified air for 48 hours.The circuit was left unsupported so that its entire weight was acting on the tracheal tube connector.There was no indication of the tube becoming disconnected when attached to the ventilation circuit.The circuit remained securely attached throughout the 48 hour period.The circuit remained attached even when the dual limb was lifted and released a number of times to increase the load on the connection.There was no indication to suggest that once the connector is pushed firmly into the tube prior to use, that it does not remain securely attached.The reported issue could not be confirmed during testing and the device was found to function as intended.Mfr# clarification: new registration number 3012307300 ((b)(4)) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4)).

• Brand Name: PORTEX® BLUE LINE UNCUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5980712
• MDR Text Key: 55789281
• Report Number: 2183502-2016-02159
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: 100/133/060
• Device Lot Number: 3151913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1