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	Serious Injury
Additional Manufacturer Narrative
Other, other text: d4: lot number, expiration date and h4: manufacture date are unknown, no information has been provided to date.Device evaluation no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number was provided, therefor no device history report (dhr) review could be completed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the child's positioning had to be changed several times in order to prevent the ventilator from "sounding occluded and the child from under-ventilating".The child should be positioned with head hyperextension to be properly ventilated.Patient suffered respiratory instability.The device was discarded after extubation.

• 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: 17777814
• Report Number: 3012307300-2023-09105
• Device Sequence Number: 6736454
• 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
• Type of Report: Initial
• Report Date (Section B): 09/19/2023

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 Catalogue Number: 100/111/025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG