MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEAL TUBE SILICONIZED ORAL/NASAL UN-CUF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/111/025
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the child is fitted with a 2.5 intubation tube.Whenever it is installed ventral on the left side, the probe does not ventilate efficiently.The ventilator rings in occlusion and the ventilation curve shows under ventilation.As soon as we reposition the child on the back the occlusion rises.Verification that there are no obstacles inside the probe that do not present.Impossible to install the child in this way which is not in match with her needs.We observed a slowing of the child's heart rate as well as only desaturation and hypercapnia, until the remobilization of the child in a position where the intubation tube allows ventilation effectively.In itself only right support in ventral and dorsal.Female, 5 days old, weight 0.7kg.

• Brand Name: PORTEX TRACHEAL TUBE SILICONIZED ORAL/NASAL UN-CUF
• 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: 17647574
• Report Number: 3012307300-2023-08508
• Device Sequence Number: 7212759
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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 Catalogue Number: 100/111/025
• Device Lot Number: 4345418
• 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: 08/07/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 5 DA
• Patient Sex: Female
• Patient Weight: 1 KG