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

Model Number	100/189/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Airway Obstruction (1699); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
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.
Event or Problem Description
It was reported that the patient who was intubated had to be extubated and re-intubated with a non saccet et tube.The et tube had to be replaced due to cuff failure.There was no patient injury reported.
Event or Problem Description
Additional info received (b)(6)22: three devices in total were used on the same patient on the same day.
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual inspection found no anomalies in the cuff, but damage was detected in the inflation line.Due the inflation line is damaged, it's not possible perform the leak functional test to confirm the leak in cuff since the inflation line must be connected to leak tester machine to allow air pass through the tube and confirm the leak in cuff.Based on the analysis conducted in the sample provided, the root cause analysis cannot be addressed due to damage in the inflation line.No corrective action required since the reported failure mode was not confirmed.E4 is unknown.Additional information received (updated b5).
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The returned sample was visually inspected and no anomalies were found in cuff, but damaged was detected in inflation line.Due to the inflation line being damaged, it's not possible perform the leak functional test to confirm the leak in cuff.The inflation line must be connected to leak tester machine to allow air pass through the tube and confirm the leak in cuff.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: no corrective action required since the reported failure mode was not confirmed.No problems or issues were identified during this device history record review.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SACETT
• 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; dublin 18; minneapolis, MN 55442
• MDR Report Key: 13508211
• Report Number: 3012307300-2022-03151
• Device Sequence Number: 4064113
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: 15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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 Model Number: 100/189/070
• Device Catalogue Number: 100/189/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 09/15/2022; 04/21/2023
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 10/14/2022; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown