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

Model Number	100/111/035
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the term baby was intubated with a size 3.5 endotracheal tube.When attempting to fix the tube, the operator experienced significant difficulty in slipping the holder onto the tube, this occurred despite the operator completely undoing the clip.The holder appeared to be too small to slip over the tube, and as a result the baby was accidentally extubated.The difficulty added some trauma to the baby, who had to be held very firmly.This issue had been experienced before, and as a result the facility staff were advised to completely release the clip before trying to fit the holder.No further patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: additional information: there was no adverse outcome as the patient was successfully re-intubated and fully releasing the clip.
Event or Problem Description
Additional information: there was no adverse outcome as the patient was successfully re-intubated and fully releasing the clip.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11742012
• Report Number: 3012307300-2021-03554
• Device Sequence Number: 4244219
• Product Code: BTR
• UDI-Device Identifier: 15019315018862
• UDI-Public: 15019315018862
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: No Information
• Device Expiration Date: 03/20/2025
• Device Model Number: 100/111/035
• Device Catalogue Number: 100/111/035
• Device Lot Number: 3955988
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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: Life Threatening