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

Model Number	198-32L
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical endotracheal tube was in use with a patient, the device was noted to be leaking air from the bronchial cuff.The cuff was noted to be damaged.No patient injury resulted.
Additional Manufacturer Narrative
One portex® endobronchial tube was returned for analysis in used condition.Upon visual inspection of the returned sample; no discrepancies were found.A syringe was used to inflate the cuff of tube; leakage was observed coming from the small tear in the blue cuff.Relevant documents were reviewed and deemed adequate.Training records, leak testing procedure, and the production line were reviewed; no discrepancies noted.Leak testing was performed on 32 units from the production floor; no discrepancies or damage were detected.Instructions for use (ifu) were reviewed and noted the following: "cuff leaks that are detected immediately following tube placement are usually due to cuff nicks from teeth or instrumentation during intubation." based on the evidence, the complaint is confirmed.However, the root cause is unknown.It is stated that the most probable root cause is that the cuff become damaged after it left the shm facilities due to the product is 100% leak tested under water.

• Brand Name: SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9418746
• Report Number: 3012307300-2019-07012
• Device Sequence Number: 19260267
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 05/08/2022
• Device Model Number: 198-32L
• Device Catalogue Number: 198-32L
• Device Lot Number: 3792424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1