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

Model Number	100/166/080
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that an endotracheal tube failed to inflate the balloon.The intubation had all been straight forward and when the anesthetist and odp could not get a seal they had to extubate and then intubate with another tube.The anesthetist then examined the et tube that caused the problem and found that it was leaking at the at the bottom of the inflation port.The customer then submerged in water and could see that it was definitely leaking from that area.Additional information received via customer response email dated 06-jul-2022: no medical intervention was required other than changing out the tube.Patient was extubated and then re-intubated with another device.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
Additional information received via customer response email 06-jul-2022: no medical intervention.Patient was extubated and then re-intubated with another device.

• Brand Name: PORTEX SILICONIZED PVC SOFT SEAL 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15160764
• Report Number: 3012307300-2022-14551
• Device Sequence Number: 5948284
• Product Code: BTR
• UDI-Device Identifier: 15019315054105
• UDI-Public: 15019315054105
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2025
• Device Model Number: 100/166/080
• Device Catalogue Number: 100/166/080
• Device Lot Number: 3977837
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 03/30/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/13/2022; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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