MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOTRACHEAL TUBES SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35W060
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the information on the website is misleading in a way from technical sheets.The information does stipulate that the cuff is an air cuff, but with low diameter, the instructions for use mentions that this is a tts cuff and it must be filled with water and not air, whereas for the sizes from 6 and above this is an air cuff must be filled with air.The same instructions for use also mentions that the silicone cuff fits flat against the inner cannula despite the fact that there is no inner cannula for these tubes.No patient injury reported.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms#(b)(4), corrected data: b1 updated to reflect product problem.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16751359
• Report Number: 3012307300-2023-04192
• Device Sequence Number: 8528648
• Product Code: BTR
• UDI-Device Identifier: 15021312014341
• UDI-Public: 15021312014341
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K792035
• 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): 04/24/2023

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: Health Professional
• Device Model Number: 35W060
• Device Catalogue Number: 35W060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown