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

Model Number	100/141/030
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, expiration date and device manufacture date is unknown, no information has been provided to date.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 et tube was defective (tube inside of the tube) making it hard to ventilate.There has been no report of observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other text: d10: device available for evaluation, h6: event methods, evaluation, and conclusion codes: updated.Two photos and one sample device were received for investigation.Both photos depict the complaint sample.The reported complaint was confirmed during visual inspection of the device, which verified the end of the connector was damaged and detached from the tube.Further examination of the damaged area determined that the connector had been previously joined to the tubing.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information the investigation confirmed the complaint, and attributed the device condition to improper use of the product.No actions have been assigned at this time.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16589361
• Report Number: 3012307300-2023-02876
• Device Sequence Number: 4937735
• Product Code: BTR
• UDI-Device Identifier: 15019315019036
• UDI-Public: 15019315019036
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100/141/030
• Device Catalogue Number: 100/141/030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 2 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Hispanic
• Patient Race: White