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

Catalog Number	100/136/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical endotracheal tube had a hole in the tubing, leading to a leakage where the inflation line is molded to the tube.As a result, an endotracheal tube change out was required.
Additional Manufacturer Narrative
Device evaluation: two portex tracheal samples were received in used condition without their original packaging.Immediate visual inspection detected holes in both sample tubes.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.Operator training records were reviewed to ensure operators are trained in bell-out, fit inflation line, and leak tests.No discrepancies were found.The bell-out and fit inflation line operations were also audited during thirty two (32) units finding no discrepancies or damaged tubes.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and investigation, the complaint was confirmed.The problem source was stated to be manufacturing and it was noted the most probable sources of the reported event were either of the following: an application of strong pressure when inserting the bradawl or a lack of detection by production personnel who performs the fit inflation line operation.Retraining was completed by the quality engineer and production supervisor for - bell out, fit inflation line, inflate cuff, and pressure decay test, emphasizing that care must be taken not to pierce the inflation channel.Also, training to ensure inflation channel is not split or pierced when using bradawl.Additionally, an image was added to the visual aid to show accepted bradawl specifications.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8270156
• Report Number: 3012307300-2019-00322
• Device Sequence Number: 11077558
• Product Code: CBI
• UDI-Device Identifier: 15019315021312
• UDI-Public: 15019315021312
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 100/136/070
• Device Lot Number: 3533963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention