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

Catalog Number	100/136/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgical procedure the anesthetic noticed that the circuit had a 90ml leak.At the end of the procedure the patient was extubated without issue.Upon examination it was found that there was a leak from the point where the pilot balloon tubing enters the main body of the endotracheal tube.The surgery was completed uneventfully.
Additional Manufacturer Narrative
Evaluation results: one portex endotracheal tube was returned for evaluation.The sample was received in used condition without its original packaging.The returned sample was visually inspected at a distance of 12" to 16" and normal conditions of illumination.A hole was identified in the tube.The following most probable root causes were identified: mixed material from set-up on the crop notch operation.Lack of detection by production personnel who performs the crop notch operation.The following action were taken based on the results of the product evaluation: re-training to the production personnel was conducted by the quality engineer on (b)(6)2019 in order to reinforce the visual inspection procedure.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• 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: 8737682
• Report Number: 3012307300-2019-02952
• Device Sequence Number: 11406047
• Product Code: BTR
• UDI-Device Identifier: 15019315021312
• UDI-Public: 15019315021312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 100/136/070
• Device Lot Number: 3738868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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