MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD, PORTEX TRACHEOSTOMY TUBE; BTO- TRACHEOSTOMY TUBE

Catalog Number 100/515/080

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

The user facility reported that the tracheostomy tube was in use with a patient for 1 day when the cuff and pilot balloon were found leaking.No permanent adverse effects to the patient were reported.

Manufacturer Narrative

Device evaluation: 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 f/u report detailing the results of the evaluation once it is completed.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Type of Device: BTO- TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD,; hythe,kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4368112
• MDR Text Key: 5112485
• Report Number: 2183502-2014-00995
• 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: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Distributor Facility Aware Date: 11/21/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/17/2014
• 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