MAUDE Adverse Event Report: ST PAUL PORTEX ENDOTRACHEAL TUBES; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/127/025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the plastic coating of stylet was detached from stylet when stylet removed from the endotracheal tube (ett) after intubation.A 10cm (centimeter) piece of plastic coating remained in the endotracheal tube (ett) which was in the patients esophagus.The patient was electively extubated due to the plastic piece in original endotracheal tube (ett) and reintubated.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16468395
• Report Number: 3012307300-2023-01903
• Device Sequence Number: 17458713
• Product Code: BTR
• UDI-Device Identifier: 15019315019807
• UDI-Public: 15019315019807
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2026
• Device Model Number: 100/127/025
• Device Catalogue Number: 100/127/025
• Device Lot Number: 4198085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 06/27/2023; 07/14/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male