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

Catalog Number	100/111/025
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that to prevent the ventilator from sounding, the child is occluded from under-ventilation, and he should be positioned with the head hyperextended to ensure correct ventilation.There is a need for repositioning the child several times and these actions determine significant respiratory deterioration.The actual device is in use with the patient and will be provided for investigation after the therapy is done.
Additional Manufacturer Narrative
Other text: d4: lot number, expiration date and h4: manufacture date are 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.
Additional Manufacturer Narrative
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX SILICONISED ENDOTRACHEL 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: 17777414
• Report Number: 3012307300-2023-09067
• Device Sequence Number: 18080142
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: 15019315018848
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 100/111/025
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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 Age: 1 YR
• Patient Sex: Male
• Patient Weight: 8 KG