MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX 7.5MM SUCTIONAID TRACHEOSTOMY TUBE; BTO - TRACHEOTOMY TUBE

Catalog Number 100/515/075

Device Problems Air Leak (1008); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the tracheostomy tube was deflating at the cuff after an unknown amount of time in situ.The user reported that the inflation line was observed to be torn.The tracheostomy tube was replaced.No adverse effects to patient reported.

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.

• Brand Name: PORTEX 7.5MM SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: BTO - TRACHEOTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; boundary rd.; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4207576
• MDR Text Key: 4983380
• Report Number: 2183502-2014-00572
• Device Sequence Number: 1
• Product Code: CAZ
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/075
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2014
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2014
• 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