MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problems Misassembled (1398); Misconnection (1399)

Patient Problems Hypoventilation (1916); Extubate (2402); No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a portex® bivona® custom flextend¿ tts¿ tracheostomy tube plastic piece between the hub and the flange was placed backwards.Due to the issue, the tracheostomy tube was unable to connect to the ventilator circuit.The patient required an emergent tracheostomy tube change due to the incident.No permanent injury was reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that a "code blue" was called after the respiratory therapist transitioned the patient from "trach mist" to a ventilator.According to the report, attempts that were made to place the ventilator tubing onto the tracheostomy tube were unsuccessful.The hub of the ventilator tubing did not appear to fit over the tracheostomy tube adaptor.The device was removed and a 5.5mm bivona® pediatric tracheostomy tube was placed and the patient immediately improved.It was reported that the flextend¿ tracheostomy tubes are very are difficult to remove.The respiratory supervisor stated that the respiratory therapist had placed the rubber piece on backwards.

• Brand Name: PORTEX® BIVONA® CUSTOM FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6498136
• MDR Text Key: 72944568
• Report Number: 3012307300-2017-00862
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention