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

Model Number	100/133/075
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three portex® endotracheal tubes were returned for analysis in used conditions.No discrepancies were found upon visual inspection.Functional testing was performed by inflating the syringe while submerged under water; leakage was observed coming from a small tear in the cuff to all 3 samples.Relevant documents were reviewed and deemed adequate.An audit of the production floor was performed by reviewing training records and relevant procedures; all deemed adequate.Thirty two samples were reviewed for tracheal inflation line and leak tests; no discrepancies or leaks were found.Based on the evidence the complaint was confirmed.However, the root cause is unknown.
Event or Problem Description
Information was received indicating that immediately following intubation of the patient with a smiths medical portex endotracheal tube, air came out of the cuff.There were no reported adverse patient effects.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim ; 6000 nathan ln n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7958675
• Report Number: 3012307300-2018-04244
• Device Sequence Number: 5522665
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: 15019315020360
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2019

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
• Device Expiration Date: 08/02/2022
• Device Model Number: 100/133/075
• Device Catalogue Number: 100/133/075
• Device Lot Number: 3463144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 12/03/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 10/11/2018; 01/03/2019
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown