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

Catalog Number	100/126/030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
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 ballard 8 fr.Inline suction catheter could not be advanced down the tubes.On two instances they have needed to re-intubate babies with an alternate tube to ensure proper bronchial hygiene.There was patient involvement and unknown adverse event reported.
Additional Manufacturer Narrative
Investigation summary: photos were provided by the customer.A ¿tracheal tube, siliconized cut-to-length, oral 3.0mm 10/bx¿ sample is possible to see in the photo, broken in the tube.According to the photos provided by the customer the failure mode was not confirmed since the photos provided by the customer do not show the reported failure mode.In case the sample was provided the complaint will be re-open to evaluate the device and make the corresponding tests.

• Brand Name: PORTEX SILICONIZED TRACHEAL TUBE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20495271
• Report Number: 9617604-2024-00821
• Device Sequence Number: 17170347
• Product Code: BTR
• UDI-Device Identifier: 15019315056765
• UDI-Public: (01)15019315056765(17)280322(10)4380606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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: Health Professional
• Device Catalogue Number: 100/126/030
• Device Lot Number: 4380606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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
• Patient Sex: Unknown
• Patient Weight: 21 KG