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

Catalog Number	100/133/065
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient use it was noticed the cuff would not inflate.Adverse patient effects are unknown.
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.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: g2 email is: regulatory.Responses@icumed.Com.Device evaluation: one device was returned for investigation.Visual inspection noted the cuff was found to have scratches on the surface.The sample looks quite used.The scratches on the cuff cause the cuff to fail to inflate.Based on the analysis performed on the sample, the reported cuff inflation / deflation problem was confirmed.The sample has the cuff scratched, in this section was found the leak.This type of scratch can be caused when the cuff inflated is in contact with some sharp edge.The unit is observed used.It seems that it got stuck during the intubation process and when pulling the device caused this leak.However, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: PORTEX TRACHEAL TUBE MAXILLO FACIAL
• 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: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18007193
• Report Number: 3012307300-2023-09896
• Device Sequence Number: 7582405
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: (01)15019315020346(11)220309(17)270215(10)4241720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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 Catalogue Number: 100/133/065
• Device Lot Number: 4241720
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/27/2023; Not provided
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 12/22/2023; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Patient Sex: Unknown