MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

Catalog Number 100/897/070

Device Problem Occlusion Within Device (1423)

Patient Problem Hypoxia (1918)

Event Date 03/27/2015

Event Type  Injury  

Event Description

User facility reported that the device was placed in use with patient with inner cannula placed in the tube.According to the reporter, the patient was discharged to home care with this device in use and patient's son was the caregiver.According to device instructions for use, this "tracheostomy tube must not be used outside an area where its use can be closely monitored such as an intensive care unit, or an intermediate care unit.It should be changed to a custom made fixed flange tracheostomy tube prior to discharge from the hospital." according to reporter, the patient while in home care had difficulty breathing and caregiver called paramedics.The patient was brought back to hospital care; according to user facility the breathing difficulty was caused by a blockage between the tube and the inner cannula and user facility reported the inner cannula was shorter than the tube.According to user facility, the patient had respiratory arrest and cardiac arrest and required resuscitation.According to reporter, hypoxic brain injury occurred.As of (b)(6), the patient was in intensive care.Additional information has been requested regarding how the device was used during homecare but has not been provided by patient's caregiver.

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 report detailing the results of the evaluation once it is completed.

• Brand Name: UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundry rd; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4765701
• MDR Text Key: 16988147
• Report Number: 2183502-2015-00313
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K083031
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2015
• Distributor Facility Aware Date: 03/27/2015
• Event Location: Home
• Date Manufacturer Received: 04/14/2015
• 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 Outcome(s): Other