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

Model Number	100/189/080
Medical Device Problem Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
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 cuff leaked and deflated upon intubation.Customer requested product return.Additional information received on 22-dec-2022 via email and attached to complaint object: customer confirmed the quantity affected.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation 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, other text: h6.Health impact and evaluation codes: updated.No product was returned there an investigation could not be conducted and the reported complaint cannot be confirmed.A device history record (dhr) review showed there were no issues or nonconformance's reported during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the investigation.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One device sample was received in used condition without the original packaging.A leak test was performed to confirm the cuff deflation problem, the sample did not pass the test.The complaint was confirmed due to a leak in the inflation line where a scratch was also noted.A root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• 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; 05-01; minneapolis, MN 55442
• MDR Report Key: 16121381
• Report Number: 3012307300-2023-00239
• Device Sequence Number: 6547460
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• 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,Followup
• Report Date (Section B): 02/14/2024

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: 03/09/2026
• Device Model Number: 100/189/080
• Device Catalogue Number: 100/189/080
• Device Lot Number: 4107106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; 11/26/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 05/30/2023; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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