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

Model Number	100/189/080
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer noticed that the intubation tube was "shedding" some sort of plastic film.This appeared to be "disintegrating" which prompted the patient to be re-intubated.The tube had been in place for twenty two (22) days.A small piece of plastic came off and stuck to the end of the fiberscope."small pieces of plastic can be placed distally at the time of tracheal aspirations by the carers, especially when they administer saline at the same time to thin the secretions".No adverse effects reported and the outcome was resolved.
Additional Manufacturer Narrative
Other text: b3: date of event is unknown, no information has been provided to date.Two (2) videos were received and reviewed confirming the complaint.No product was returned therefore functional testing could not be completed.A root cause could not be determined from the videos and no product was returned for device analysis.A device history record (dhr) review showed no discrepancies or non-conformances during the manufacturing of the reported lot number.The manufacturer will continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF 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: 17303239
• Report Number: 3012307300-2023-07120
• Device Sequence Number: 20459705
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2026
• Device Model Number: 100/189/080
• Device Catalogue Number: 100/189/080
• Device Lot Number: 4161892
• 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: 01/18/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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
• Patient Sex: Unknown