MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. SUCTIONAID PROFILE TRACHESOTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/515/075

Device Problem Hole In Material (1293)

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

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device and an investigation has not been initiated.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

This event occured in (b)(6).The customer reported that the suction aid profile tracheostomy tube was checked for leak prior to use and confirmed no leakage.The patient is ventilator dependent and is not able to breathe without a tube in place.The patient had a big tumor mass at the neck so it was difficult to adjust the tube position.The doctor manipulated the tube to find the best position when the ventilation volume dropped.The tube was changed and the doctor found the tear on the cuff.There was no injury to the patient.

Manufacturer Narrative

One used portex® 7.5mm blue line ultra® suction aid tracheostomy tube was returned for investigation.The device was received without its original packaging.Visual inspection of the device was conducted at a distance of 12" to 24" and under normal conditions of illumination and a hole was found in the device cuff.Investigation was unable to determine the root cause of the cuff leak.(b)(4).

• Brand Name: SUCTIONAID PROFILE TRACHESOTOMY 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: 5841170
• MDR Text Key: 50978617
• Report Number: 2183502-2016-01643
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 100/515/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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