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

Catalog Number	100/133/075
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
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.
Additional Manufacturer Narrative
One 8.0 aire cuff adult tracheostomy tube was returned with the airway inflation balloon completely detached from the airway line.There were no details other than the "cuff hose ripped" provided in the complaint.The presence of the airway line inside the balloon showed that the bond was sufficient in retaining the airway line within the balloon as the airway line broke outside the balloon.The airway line was found to be stretched near the failure point leading the investigation to conclude that excessive force was applied to the airway line causing the balloon to eventually detach from the line.The investigation did not reveal any intrinsic manufacturing defects with the returned devices.The investigation concluded that the defect was not the result of a manufacturing defect, so a corrective action will not be issued.Smiths medical regularly analyzes data and trends and will take further actions accordingly.
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.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7845546
• Report Number: 3012307300-2018-04158
• Device Sequence Number: 13849243
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: 15019315020360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• 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,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
• Operator of Device: No Information
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: 100/133/075
• Device Lot Number: 3463144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/11/2018; 12/03/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/05/2018; 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1