MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBE, SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/166/075
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the inflation line was detached from the tube after intubated for fifteen minutes.Steps taken to resolve the issue was to use a new one.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No product sample was received; therefore, visual and functional testing could not be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one sample was received.Sample was visually inspected and no damage or anomaly was observed.During the functional testing inflation test, air could not be retained by the cuff.The cuff was submerged in a water bath and a leak was observed on the surface of the cuff.The customer reported complaint was able to be confirmed.The cause of the issue is unknown.The complaint of inflation line separation could not be confirmed due to the sample in question not being returned.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
Additional Manufacturer Narrative
Correction to h6 codes as the device for this complaint was not returned for evaluation.The complaint of inflation line separation could not be confirmed due to the sample in question not being returned.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PORTEX ENDOTRACHEAL TUBE, SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21147970
• Report Number: 9617604-2025-00043
• Device Sequence Number: 9097512
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: (01)15019315054099(17)280119(10)4367780
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2025

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 Catalogue Number: 100/166/075
• Device Lot Number: 4367780
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 03/04/2025; 05/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/06/2025; 03/31/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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