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

Model Number	100/111/040
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Airway Obstruction (1699); Insufficient Information (4580)
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.
Event or Problem Description
Additional information: there was no adverse outcome as the patient was successfully re-intubated and fully releasing the clip.
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.
Additional Manufacturer Narrative
Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11741768
• Report Number: 3012307300-2021-03553
• Device Sequence Number: 19894618
• Product Code: BTR
• UDI-Device Identifier: 15019315018879
• UDI-Public: 15019315018879
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2023

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
• Device Model Number: 100/111/040
• Device Catalogue Number: 100/111/040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 04/21/2023
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/25/2021; 04/27/2023
• 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