MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBES POLAR

Model Number	100/136/075
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 received a smiths medical intubation|portex endotracheal tubes polar malfunctioned.No anomaly in the product was observed at a pre-use check.However, after intubating it into the patient using an airway scope, when the customer attempted to put air into it, he noticed the cuff did not inflate.Also, he heard a sound of air leakage from the pilot balloon.No patient injury.
Additional Manufacturer Narrative
One portex endotracheal tube (ett) was returned for analysis in used conditions.No discrepancies were observed upon visual examination.The ett was then inflated while submerged under water; leakage was observed coming out of a tear in the pilot balloon.An audit of the production floor was then performed.Training records, bell-out, fit inflation line and leak test operations were reviewed, the production line was reviewed, inflation line subassembly operation were all reviewed; no discrepancies observed.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.

• Brand Name: PORTEX
• Common Device Name: TUBES POLAR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10302613
• Report Number: 3012307300-2020-07461
• Device Sequence Number: 19005228
• Product Code: BTR
• UDI-Device Identifier: 15019315021329
• UDI-Public: 15019315021329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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 Expiration Date: 08/01/2024
• Device Model Number: 100/136/075
• Device Catalogue Number: 100/136/075
• Device Lot Number: 3852800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/02/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1