MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; ENDOTRACHEAL TUBE

Model Number	8.0MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes malfunctioned.Reported the pilot balloon detached during intubation ,physician managed to inflate cuff by applying adhesive tape.Unable to deflate cuff during extubation.No complications to patient.
Additional Manufacturer Narrative
Two photos and a physical sample were returned for analysis.In the two photos received, no defects could be found.On the physical sample, the inflation line was found detached.The complaint was confirmed.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX
• Common Device Name: ENDOTRACHEAL TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11402280
• Report Number: 3012307300-2021-01678
• Device Sequence Number: 11608581
• Product Code: BTR
• UDI-Device Identifier: 15019315050800
• UDI-Public: 15019315050800
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 04/29/2021

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 Expiration Date: 05/09/2024
• Device Model Number: 8.0MM
• Device Catalogue Number: 100/110/080
• Device Lot Number: 3818428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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