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

Model Number	100/166/075
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® endotracheal tube was noted to not maintain air pressure and a leakage was confirmed.Subsequently, a trach tube change out was performed.There were no reported adverse effects.
Additional Manufacturer Narrative
One portex® endotracheal tube from p/n 100/166/065 with lot number reported as unknown 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; no discrepancies were observed.The returned sample was inflated using a syringe and the product was submerged under water in order to detect any leakage; leakage was observed coming out from a tear in the cuff.Relevant documents were reviewed and deemed adequate and correct with respect to testing and inspection activities.The most probable cause is that the cuff was damaged after it left the manufacturing facilities due to the product being 100% leak tested.

• 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
• MDR Report Key: 9946664
• Report Number: 3012307300-2020-02767
• Device Sequence Number: 11621874
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: 15019315054099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/15/2020

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: No Information
• Device Model Number: 100/166/075
• Device Catalogue Number: 100/166/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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