MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNCUFFED NEONATAL/PEDIATRIC TRACHEAL TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	H4022S
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a patient was electively re-intubated with a 3.5 mm smiths medical portex® uncuffed neonatal/pediatric endotracheal tube when the packaging stated 3.0 mm.It was reported that the physician would have preferred 3.0 mm size but the patient became "stressed" after insertion of the larger endotracheal tube (ett).No change out to the correct size was performed due to the status of the patient being "stressed" with reported clinical injury per physician.This complaint will be reported as serious injury due to the reported serious injury.The available information suggests that the smiths medical product could have led to a life-threatening injury / illness.

• Brand Name: PORTEX® UNCUFFED NEONATAL/PEDIATRIC TRACHEAL TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7079214
• Report Number: 3012307300-2017-02508
• Device Sequence Number: 1004700
• Product Code: JOH
• UDI-Device Identifier: 15019315077586
• UDI-Public: 15019315077586
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 07/04/2020
• Device Catalogue Number: H4022S
• Device Lot Number: 3454189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/04/2017
• 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