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

Model Number	100/110/080
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that pre-testing of this smiths medical portex endotracheal tubes, leakage of air from the cuff was detected.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation- the device was returned for evaluation.The device was examined; this showed no obvious defects.The returned device was given functional testing; this showed leakage of the airway in the area between pilot balloon and pilot valve.The device issue was confirmed.The issue was determined most likely as damage during use; this device type is 100% leak tested prior to packaging.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• 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: 11217635
• Report Number: 3012307300-2021-00632
• Device Sequence Number: 11664423
• Product Code: BTR
• UDI-Device Identifier: 15019315050800
• UDI-Public: 15019315050800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Expiration Date: 06/01/2025
• Device Model Number: 100/110/080
• Device Catalogue Number: 100/110/080
• Device Lot Number: 3977893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/25/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1