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

Catalog Number	60N040
Medical Device Problem Codes	Device Alarm System (1012); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pulmonary Emphysema (1832); Encephalopathy (1833); Hypoxia (1918); Pneumothorax (2012)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6491307
• Report Number: 3012307300-2017-00857
• Device Sequence Number: 1082034
• Product Code: BTO
• UDI-Device Identifier: 15021312005714
• UDI-Public: 15021312005714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2021
• Device Catalogue Number: 60N040
• Device Lot Number: 3288134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Disability
• Patient Age: 3 MO
• Patient Weight: 1