MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60N040

Device Problems Device Alarm System (1012); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Pulmonary Emphysema (1832); Encephalopathy (1833); Hypoxia (1918); Pneumothorax (2012)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number: k912469 and k083641.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® uncuffed neonatal tracheostomy tube was intubated in the patient during an operation.At 2:15am on the next day, an alarm on the artificial respirator was heard and it was observed that the tracheostomy tube had come out by accident.It was unknown how the tube was secured to the patient.The tube was checked in accordance with its instructions for use prior to placement.A resuscitator was used to arouse the patient.The tip of the tube was under the patient's skin and as a result, a subcutaneous emphysema appeared and caused a pneumothorax.The patient went into cardiac arrest and the tracheostomy tube was removed with haste and replaced with an endotracheal tube, which resuscitated the patient.Due to the incident, the patient was hypoxic for 23 minutes and suffered hypoxia-induced encephalopathy and epilepsy.The event was considered ongoing.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE
• 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6491307
• MDR Text Key: 72755448
• Report Number: 3012307300-2017-00857
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005714
• UDI-Public: 15021312005714
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2021
• Device Catalogue Number: 60N040
• Device Lot Number: 3288134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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): Life Threatening; Disability
• Patient Age: 3 MO
• Patient Weight: 1