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

Model Number	100/141/030
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Insert (1316); Obstruction of Flow (2423); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was intubated with a 2.5 endotracheal tube by the pediatrician.Not ventilating appropriately and requiring high pressures.Reintubated with 3.0 endotracheal tube per anesthesia.Medical staff remember having difficulty with the stylet pre and post second intubation.Ventilator pressures were still high, so the baby was reintubated with a 3rd 3.0 endotracheal tube with improvement in oxygenation and pressures.Upon removal of the second endotracheal tube, it appeared that there was a 2.0 endotracheal tube stuck inside the 3.0 endotracheal tube.There has been no report of clinical affects.
Additional Manufacturer Narrative
D4: 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.
Additional Manufacturer Narrative
Other text: additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• 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: 16709907
• Report Number: 3012307300-2023-03904
• Device Sequence Number: 14935097
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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?: 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown