MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the pilot balloon to a smiths medical portex endotracheal tube was observed to be leaking.There were no reported adverse effects.
Event or Problem Description
Investigation completed and will be summarized in h 10.
Additional Manufacturer Narrative
Other text: investigation received on a smiths medical intubation|portex endotracheal tubes siliconized.Three pictures received for evaluation.Used sample for testing with evaluation p/n 100/166/070 with lot number reported as unknown during functional testing the complaint was confirmed when submerging under water.Quality review was opened with no discrepancies revealed.The manual was reviewed and suggested instruction may have caused incident.According to below statement this may have been cause of incident.10016024-001 rev.100 instructions for use - portex tracheal tubes was reviewed; in precautions section on point 6 states guard against cuff damage by avoiding contact with sharp edges?.Per mp tmfl-tj070 rev 107.
Additional Manufacturer Narrative
Investigation received on a smiths medical intubation|portex endotracheal tubes siliconized.Three pictures received for evaluation.Used sample for testing with evaluation p/n 100/166/070 with lot number reported as unknown during functional testing the complaint was confirmed when submerging under water.Quality review was opened with no discrepancies revealed.The manual was reviewed and suggested instruction may have caused incident.According to below statement this may have been cause of incident.10016024-001 rev.100 ? instructions for use - portex tracheal tubes was reviewed; in precautions section on point 6 states? guard against cuff damage by avoiding contact with sharp edges?.Per mp tmfl-tj070 rev 107.
Event or Problem Description
Investigation completed and will be summarized in h 10.
Additional Manufacturer Narrative
Other, other text: investigation received on a smiths medical intubation|portex endotracheal tubes siliconized.Three pictures received for evaluation.Used sample for testing with evaluation p/n 100/166/070 with lot number reported as unknown during functional testing the complaint was confirmed when submerging under water.Quality review was opened with no discrepancies revealed.The manual was reviewed and suggested instruction may have caused incident.According to below statement this may have been cause of incident.10016024-001 rev.100 ? instructions for use - portex tracheal tubes was reviewed; in precautions section on point 6 states ?guard against cuff damage by avoiding contact with sharp edges?.Per mp tmfl-tj070 rev 107:.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10547287
• Report Number: 3012307300-2020-09440
• Device Sequence Number: 3344790
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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,Followup,Followup
• Report Date (Section B): 11/24/2020

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 Model Number: 100/166/070
• Device Catalogue Number: 100/166/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 10/26/2020; 10/26/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/23/2020; 11/24/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1