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

Model Number	35W065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.A product sample was received for evaluation.Visual inspection revealed no defects.During functional testing, as per procedure, when air as applied to the device and no leaks were detected.The investigation did not reveal any intrinsic manufacturing defects with the returned device.The investigation did not confirm a leak.Data and trends regularly analyzed and further actions will be taken accordingly.
Event or Problem Description
It was reported that after checking the cuff, the user noticed that it was leaking.The user tested the respirator twice and no issued observed.After inflating the cuff with a pressure above 120, no leakage observed.No patient injury reported.Additional information received on (b)(6) 2021: no injury or clinical consequence observed.After cuff's pressure monitoring a second physician decided the cuff was over-inflated.Patient's info provided.

• 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: 16751240
• Report Number: 3012307300-2023-04191
• Device Sequence Number: 3379502
• Product Code: BTR
• UDI-Device Identifier: 15021312014358
• UDI-Public: 15021312014358
• 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
• Report Date (Section B): 04/17/2023

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 Expiration Date: 11/19/2024
• Device Model Number: 35W065
• Device Catalogue Number: 35W065
• Device Lot Number: 3890363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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 Age: 11 YR
• Patient Sex: Female
• Patient Weight: 75 KG