MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/189/075
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cuff leak/deflate upon intubation.No injury.Customer confirmed for the quantity affected: five (5) trachs.
Additional Manufacturer Narrative
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
Health impact and evaluation codes: updated.No photos or product was returned therefore an investigation could not be completed.A device history record (dhr) review showed there were no issues, nonconformance's reported during the manufacturing of the reported lot number.No corrective actions were taken as the complaint was not confirmed.If the product is returned the manufacturer will re-open the investigation.

• Brand Name: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA
• Common Device Name: TUBE, TRACHEOSTOMY (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; 05-01; minneapolis, MN 55442
• MDR Report Key: 16125205
• Report Number: 3012307300-2023-00282
• Device Sequence Number: 18249523
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: 15019315059537
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2026
• Device Model Number: 100/189/075
• Device Catalogue Number: 100/189/075
• Device Lot Number: 4177259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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: Life Threatening
• Patient Sex: Unknown