MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBE W HOLDER AND CONNECTOR; TUBE, TRACHEAL W WO CONNECTOR

Model Number	100/166/080
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review (dhr) could not be performed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no discrepancies were observed.Functional testing performed and the returned sample was inflated using a syringe, no cuff deflating was found.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.D5 is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that when inflating and deflating the cuff in a pre-use check, the customer felt something was wrong with it.So he did not use the product.No patient injury was reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBE W HOLDER AND CONNECTOR
• Common Device Name: TUBE, TRACHEAL W WO CONNECTOR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; sapporo city, hokkaido; minneapolis, MN 55442
• MDR Report Key: 15353853
• Report Number: 3012307300-2022-17664
• Device Sequence Number: 12218895
• Product Code: BTR
• UDI-Device Identifier: 15019315054105
• UDI-Public: 15019315054105
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2022

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
• Device Model Number: 100/166/080
• Device Catalogue Number: 100166080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown