MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE; BTO - TRACHESTOMY TUBES

Catalog Number 100/515/080

Device Problem Hole In Material (1293)

Patient Problem Extubate (2402)

Event Date 06/03/2014

Event Type  Injury  

Event Description

A report was received stating that the listed tracheostomy tube was found leaking at the cuff immediately upon use.An exchange of the tracheostomy tube was required.User facility reported the leaking was caused by a hole in the cuff, which was observed after device removal.No permanent adverse effects to patient reported.

Manufacturer Narrative

Device evaluation: one used sample was returned and examined.Upon pressurization, the cuff was found to have a small tear located where the cuff is bonded to the tube.All inflated air immediately escaped through the tear; the cuff was not able to be inflated.Manufacturing does a 100% inflation test of the cuffs and had the tear been there at the time it would have been detected and scrapped.There was no evidence found to suggest the event was caused from an intrinsic defect in the product.

• Brand Name: PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: BTO - TRACHESTOMY TUBES
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry rd.; hythe; kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3925383
• MDR Text Key: 4585726
• Report Number: 2183502-2014-00461
• 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: Other
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2014
• Distributor Facility Aware Date: 07/03/2014
• Event Location: Hospital
• Date Manufacturer Received: 06/04/2014
• 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: Unknown
• Patient Sequence Number: 1