MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG PORTEX® BLUE LINE UNCUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/506/050

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

This event occured in (b)(6).The customer reported that the device failed in the patient by detaching from the mouth piece of the tracheostomy after 22 days of use.No patient or clinical injury.Unknown patient's condition at this time.

Manufacturer Narrative

(b)(4).No product return.

• Brand Name: PORTEX® BLUE LINE UNCUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana 55425 ; MX 55425
• 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: 5777357
• MDR Text Key: 49022401
• Report Number: 2183502-2016-01387
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: MU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 100/506/050
• Device Lot Number: 2748208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 3 YR
• Patient Weight: 15