MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	H4022S
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A baby was electively re-intubated by physician.Picked up an unopened ett that said it was a 3.0 and it was placed into the baby's trachea.Upon further examination, the ett was actually a 3.5.It was packaged in a 3.0, sealed from the factory, package.Physician would not put the smaller ett in the trachea as the baby had been stressed out enough for the moment.Unopened package marked 3.0 et but actually held a 3.5 et.It was noticed after the baby was intubated.Rt supervisor went through all of our current stock of et tubes and did not find any other mismarked packages.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7024670
• Report Number: 7024670
• Device Sequence Number: 1275139
• Product Code: BTR
• UDI-Device Identifier: 15019315077586
• UDI-Public: (01)15019315077586(17)200704(10)3454189
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017
• Report Date (Section F): 10/20/2017

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: Unknown
• Device Expiration Date: 07/04/2020
• Device Model Number: H4022S
• Device Lot Number: 3454189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Date Report Sent to FDA: 10/20/2017