MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; JOH - TRACHEOSTOMY TUBE

Catalog Number 60PFSS35

Device Problems Occlusion Within Device (1423); Sticking (1597)

Patient Problems Airway Obstruction (1699); Extubate (2402)

Event Type  Injury  

Event Description

A report was received stating that the device was used with a (b)(6) patient who reportedly pulled on his tracheostomy tube.The device became wedged in the patient's stoma and an emergency tracheostomy tube change was required as the patient's airway became obstructed.No incident related medical sequela was reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufactured will file a follow-up report detailing the results of the evaluation.

• Brand Name: PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Type of Device: JOH - TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; gary IN
• Manufacturer (Section G): SMITHS MEDICAL MD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4681839
• MDR Text Key: 5714440
• Report Number: 2183502-2015-00218
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Lay User/Patient
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 60PFSS35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2015
• Event Location: Home
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR