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
Event or Problem Description
It was reported that the customer experienced difficulty during use.If they place the child in the left prone position, the ventilator sounds in ventilation occlusion.The ventilation curve shows that the child is under-ventilated, despite an adapted position (probe not angled, child's head in the right axis).This requires the head to be positioned during care (dorsal decubitus) to ensure approximate ventilation.Positioning the child in the right prone position poses no problem.Ventilation is guaranteed and effective.The customer has said that the device is not available for return as the probe is still in place on the patient.Desaturation of the child was observed, as well as a slowing of the heart rate and an increase in transcutaneous capnia.This resulted in significant destabilization for a 600-gram child.
Additional Manufacturer Narrative
Other, other text: 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 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: 17637443
• Report Number: 3012307300-2023-08418
• Device Sequence Number: 20456052
• 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
• Report Date (Section B): 08/28/2023

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: 08/28/2023
• 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: 8 DA
• Patient Sex: Male
• Patient Weight: 1 KG