MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67SP035
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that after a smiths medical tracheostomy tube had been placed, it was noted to be in the incorrect size.The intended size was 3.5 neonatal (34 mm), but the actual size was 3.5 pediatric (40mm).It was further noted that the box of the original tracheostomy tube had incorrect labeling from the manufacturer.Although the box is labeled "neonatal" it actually has the dimensions and product number of a pediatric tube.
Additional Manufacturer Narrative
Two photographs were returned for evaluation.Upon further investigation of the reported complaint, the label was able to be printed both with the neonatal format and pediatric part number.This confirms the reported customer complaint.The cause of issue was determined to be the manufacturer personnel.
Event or Problem Description
Additional information provided that patient is currently receiving care in the neonatal intensive care unit.The incident was reported to be resolved.

• Brand Name: PORTEX® BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY 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: 8270158
• Report Number: 3012307300-2019-00324
• Device Sequence Number: 16470460
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 67SP035
• Device Lot Number: 3272963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/14/2019; 03/18/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/15/2019; 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 2