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

Catalog Number	100/110/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the cuff a smiths medical endotracheal tube was unable to be inflated during a pre use check.
Additional Manufacturer Narrative
One endotracheal tube was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device then underwent functional testing by inflating the cuff with a syringe and subsequently submerging under water.As a result, a leak was observed to be coming from a small tear in the cuff.This confirms the reported customer complaint.Production performs a 100 percent pressure decay test and visual inspection to the cuff upon manufacturing the product.The most probable cause of issue has been determined to be that the cuff was damaged after it left the shm facilities.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8524075
• Report Number: 3012307300-2019-02085
• Device Sequence Number: 2689415
• Product Code: CBI
• UDI-Device Identifier: 15019315050787
• UDI-Public: 15019315050787
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032112
• 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): 08/09/2019

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 Catalogue Number: 100/110/070
• Device Lot Number: 3689232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1