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

Catalog Number	100/111/025
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
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 tubes are so loose that they cannot be intubated with¿.The products were faulty when intubating the patient.The patient was not injured but relatives became concerned when intubation failed and was delayed.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one opened unit and eight sealed units were returned for investigation.No discrepancies were found in the samples returned, the complaint was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• 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: 18937456
• Report Number: 9617604-2024-00242
• Device Sequence Number: 20539742
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: (01)15019315018848(17)280704(10)4414383
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 100/111/025
• Device Lot Number: 4414383
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown