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

Model Number	100/110/075
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex endotracheal tube did not inflate.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation|portex endotracheal tubes.Complaint of tube leaking was confirmed.Evaluation was done on p/n 100/110/075 l/n 3821748.Visual inspection revealed no abnormalities at the distance of 12 to 16.When functional testing was done by inflating balloon with syringe and submerging in water the leakage was coming out of a small tear in the cuff.Pictures were provided.Engineering process reviewed and manufacturing, which revealed device passed all testing prior to release of product as the manufacturing revealed 100% pass all forms of pre testing.The theory of leak is believed to occur after leaving manufacturing and occurred with undetected sharp edges prior to patient placement.
Event or Problem Description
Investigation completed and summarized in h 10.

• 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: 10171482
• Report Number: 3012307300-2020-06008
• Device Sequence Number: 11298401
• Product Code: BTR
• UDI-Device Identifier: 15019315050794
• UDI-Public: 15019315050794
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/01/2024
• Device Model Number: 100/110/075
• Device Catalogue Number: 100/110/075
• Device Lot Number: 3821748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1